Join Our Team at Trelleborg Medical Solutions!

Imagine working for one of the leading contract manufacturers in the world, nestled just 30 miles from California’s stunning Central Coast. At Trelleborg Medical Solutions, we are not just a premier manufacturer of life-saving medical components; we are a forward-thinking company committed to excellence and innovation. Our journey in lean manufacturing has been ongoing for years, and we are on the path to becoming a showcase of excellence in the medical industry. 

Seize this rare opportunity to be part of a medical solutions business with over 100 years of history, all while enjoying the benefits of living in one of California’s most desired locations!

Why join us?

As a valued Trelleborg team member, you will enjoy:

• Life Insurance
• Medical Insurance
• Vision Insurance
• Dental Insurance
• 401(k) plan
• Generous PTO plan
• 12 paid holidays

Position: Senior Quality Systems Specialist

Trelleborg Medical Solutions is currently accepting application for a Senior Quality Systems Specialist (QSS). The Senior QSS is focused on the maintenance of the Quality Management System (QMS) to ensure compliance with regulatory, quality, company policies and manufacturing requirements.

Key Responsibilities:

• Supports all aspects of the internal audit program, ISO notified body audits, customer audits and FDA inspections, including but not limited to:
  • Serve as an auditor for internal audits
  • Create and maintain internal audit schedule
  • Audit controlled document files in preparation for regulatory inspections and provides support during regulatory inspections and client audits
  • Initiate and execute audits, including developing and documenting the audit plan, leading the audit, generating the audit report, and tracking subsequent actions with the team
  • Provide support during external audits including scheduling, hosting, preparing audit responses
  • Work with subject matter experts to ensure audit record content is accurate, well documented, and meets the requirement of the process
• Develops metrics and performs trend analysis of key QS areas such internal and external audit findings, CAPAs, nonconforming material, training, deviations, etc. to identify areas for improvement. Escalates trends to an appropriate quality system such as CAPA or CI; presents analysis to management
• Supports maintenance of the CAPA program
  • Serves as CAPA Owner as needed, driving necessary investigation, correction, and corrective/preventive actions
  • Ensures all internal and external audit findings are entered into the CAPA system, assigned to the appropriate personnel, and are completed in accordance to the CAPA procedures, within specified time periods
  • Approve corrective action plans and verify effective and timely implementation of corrective actions for audit nonconformities
• Oversees completion and control of customer questionnaires and other customer-required documents
• Initiates, facilitates and/or manages projects to expand, change, enhance and improve the quality system, as assigned
• Supports and coordinates activities related to nonconforming material, complaint/customer feedback, deviations, RMA, and CAPA processes
• Provides quality system training for the organization as needed
• Manages review of documents to ensure ISO/FDA compliance of controlled documents lifecycle including annual review management
• Own or co-lead strategic quality initiatives, such as QMS harmonization, digital transformation, or audit program redesign.
• Communicate quality system changes effectively across the organization, ensuring understanding and adoption
• Own or support projects and associated activities to ensure ongoing compliance as related to QMS.
• Design and deliver targeted training programs based on audit findings, CAPAs trends, or regulatory updates.
• Mentor and train junior QS Specialists, auditors, and CAPA owners.
• Own complex CAPAs or systemic issues that require cross-departmental or cross-site coordination.
• Perform deep-dive trend analysis across multiple quality subsystems and present findings to senior leadership. Recommend strategic actions based on data insights (e.g., training needs, process changes, risk mitigation).
• Develop and implement enhancements to the QMS based on audit trends, CAPA effectiveness, and regulatory changes. 

Education and Experience:

Required:

• Minimum of 2 year degree in Quality, Regulatory, Manufacturing or related field; OR certificate in Regulatory Science or Medical Product Development plus 1 year of regulated industry work experience
• 3+ years of quality/regulatory experience in medical device or related industry
• 2+ year experience conducting investigations and root cause analysis for complex/advanced issues

Desired:

• 4 year degree in Quality, Regulatory, Manufacturing or related field
• ISO13485:2016 and/or ISO9001:2015 Auditor Certification
• Knowledge and experience with GMP/ISO Standards: ISO 9000/9001, ISO 13485, and FDA 21CFR 820/11 (4/210/211 as applicable)

 Salary: $70,000-$85,000 DOE

Die Trelleborg Sealing Solutions Switzerland AG ist ein führender Entwickler, Hersteller und Lieferant von Flüssigsilikonteilen für anspruchsvolle Anwendungen in der Medizintechnik, pharmazeutischen Industrie, Automobilindustrie und der Nahrungsmittel- und Getränkeindustrie. Wir sind zertifiziert nach ISO 9001, IATF 16949, ISO 13485 und ISO 14001 und zählen rund 140 Mitarbeitende. Unter anderem stellen wir 2-K-Formteile sowie Teile für die Medizinbranche im Reinraum her.

Zur Verstärkung unseres Teams suchen wir am Standort Stein am Rhein zum nächstmöglichen Zeitpunkt einen

Quality Manager (m/w/d)

Ihre Mission:

Als Quality Manager sind Sie die treibende Kraft hinter der Sicherstellung und kontinuierlichen Weiterentwicklung unseres Qualitätsmanagementsystems (QMS). Sie fördern aktiv eine Unternehmenskultur der kontinuierlichen Verbesserung und Teamarbeit und agieren als zentrale Schnittstelle zwischen Geschäftsführung, operativen Bereichen und externen Stakeholdern. Mit Ihrer proaktiven Haltung treiben Sie Veränderungen und Qualitätsinitiativen voran und tragen massgeblich zur Einhaltung regulatorischer Anforderungen sowie zur Kundenzufriedenheit bei.

Hauptaufgaben und Verantwortlichkeiten:

• Strategische Verantwortung:

• Berichterstattung zur Leistung des QMS im Rahmen von Management-Review-Sitzungen

  Vorbereitung von Tagesordnungen und Protokollen für Management-Reviews

  Vertretung der Geschäftsführung bei internen und externen Audits

  • Qualitätsmanagement & Compliance:

• Sicherstellung, dass alle QMS-relevanten Prozesse etabliert, implementiert und aufrechterhalten werden

  Förderung des Bewusstseins für regulatorische und kundenspezifische Anforderungen im gesamten Unternehmen. Überwachung und Koordination von Kundenanforderungen, behördlichen Vorgaben und internen Audits

  • Operative Qualitätssicherung:

• Planung und Kontrolle von Programmen zur Sicherstellung der Produktqualität über alle Phasen hinweg (Einkauf, Produktion, Fertigwaren). Genehmigung und Pflege aller QS-Dokumente, inkl. QSM, SOPs und Arbeitsanweisungen. Verantwortung für Lieferantenbewertungen, Prüfungen, Reklamationsmanagement und CAPA-Prozesse

  • Systeme & Prozesse:

• Leitung des internen Auditprogramms inkl. Planung, Durchführung und Freigabe Betreuung des Kalibrierungssystems, Schulungsprogramms und Dokumentenkontrollsystems Unterstützung bei Validierungsaktivitäten und Genehmigungen

  • Kommunikation & Schulung:

• Durchführung von qualitätsrelevanten Schulungen für Mitarbeitende

  Pflege von Qualitätsvereinbarungen mit Kunden

Ihr Profil:

Abgeschlossenes Studium im Bereich Qualitätsmanagement, Ingenieurwesen, Naturwissenschaften oder vergleichbare Qualifikation. Mehrjährige Berufserfahrung im Qualitätswesen, idealerweise in einem regulierten Umfeld (z. B. MedTech, Pharma). Fundierte Kenntnisse in ISO 9001 und ISO 13485, CAPA, Auditmanagement und regulatorischen Anforderungen. Ausgeprägte Kommunikationsfähigkeit, Durchsetzungsstärke und Leadership-Kompetenz. Sehr gute Deutsch- und Englischkenntnisse in Wort und Schrift

Wir bieten:

• Eine verantwortungsvolle Schlüsselrolle mit hoher Sichtbarkeit im Unternehmen
• Gestaltungsspielraum für die Weiterentwicklung des QMS
• Kollegiales Arbeitsumfeld mit flachen Hierarchien
• Attraktive Vergütung und Weiterbildungsmöglichkeiten

Bereit, Qualität neu zu definieren?
Dann freuen wir uns auf Ihre Bewerbung unter Angabe Ihrer frühestmöglichen Verfügbarkeit und Ihrer Gehaltsvorstellungen. 

Bei Fragen stehe ich Ihnen gerne zur Verfügung: Jennifer Lawrenz-Mancino, HR, Tel: +41 52 742 01 73

About the Company

Pawling Engineered Products, LLC. is a leading global specialty rubber products manufacturer. We produce highly specialized and innovative elastomeric products designed to withstand the rigorous requirements of the world’s leading original equipment manufacturers, designers, engineers and new product developers. These customers rely on our inflatable and compression seals, gaskets, clamps and other specialty rubber products for a wide range of applications in dominant industries and emerging technologies. Located in Pawling, NY. We are proud to be a part of Trelleborg since October, 2022.

About the Role

Lead the Quality Team in direct support of manufacturing. Drive continuous improvement in product quality and compliance while partnering with production, and process engineering teams in achieving customer, cost and delivery objectives. Assess performance against and develop quality policies that help to ensure products meet a high standard of customer satisfaction and conform to global standards and regulatory requirements. Own and manage quality discrepancies related to process, product or customer feedback. May serve as liaison between the Pawling facility and various government agencies, customer contacts and External 3rd Party auditors.

Responsibilities

• Manage manufacturing quality resources and daily operations of the team.
• Manage systems, complaint resolution, and in-process & Final Quality Process.
• Ensure customer requirements as identified in quality and technical agreements are reviewed, align with organizational capabilities, and are satisfied within existing or new quality system procedures or work instructions.
• Ensure applicable regulations and standards are followed, inclusive of ISO9001, 21 CFR50 Appendix B, REACH and RoHS, and related ancillary standards.
• Coordinate and lead all regulatory inspections, customer and quality system audits.
• This position serves as contact with outside regulatory agencies when needed.
• Partner with operations and engineering to ensure processes are capable and able to yield products that meet customer and quality requirements.
• Review any changes to the Company’s Quality Policies, Procedures and Work Instructions to ensure they can effectively convey information and requirements and provide oversight to ensure they are communicated as appropriate.

Qualifications

Required:

• Bachelor’s degree in engineering (Mechanical, Electrical, Industrial or Chemical) or related field.
• Master’s degree preferred.
• 6 sigma black belt or other structured problem-solving coursework.
• In lieu of a bachelor’s degree, you must have Quality Management experience.

Desired:

• 8 years of experience in Quality Engineering or Continuous Improvement.
• 2 years of experience in a leadership or management role.
• Experience and ability to mentor and support others with Advance Quality Planning activities, including the development of potential Failure Mode Effects Analysis (FMEAs) Control Plans, Process Flow Diagrams, Production Part Approval (PPAP) documents.
• Experience and ability to mentor and support others with Measurement System Analysis (MSA), including in the use of inspection procedures, measuring equipment, blueprint reading, gage R&R studies, and statistical process control.
• Possesses theoretical knowledge and current practical experience in root cause analysis and preventive actions, knowledge of Lean Enterprise and six sigma methodology: proficient computer skills and ability to supply presentations.
• Proven experience in managing multiple continuous improvement projects.
• Rubber, silicone experience preferred.
• Experience in representing organizations in customer and agency audits.

Required Skills

• Strong leadership skills.
• Superior skills in planning, organizing and motivational skills are a must.
• Excellent written and verbal communication skills.
• Excellent interpersonal and presentation skills.
• Excellent math skills.

Benefits

• Medical, dental, vision, and disability benefits
• Healthcare and dependent care FSA and HSA programs
• Bonus/incentive opportunity
• Paid Time Off
• Paid Parental Leave
• Reward and recognition programs
• Training and development
• 401(k) retirement savings plan with company match
• Tuition reimbursement
• Company Paid Life Insurance: Employee / Spouse / Child
• Supplemental Disability and Life Plans available
• Employee Assistance Program (EAP)

Pay range and compensation package

$100,000 to $120,000 depending on experience

ITAR Statement

This position requires the use of information that is subject to the International Traffic in Arms Regulations (ITAR). All applicants must be U.S. persons within the meaning of ITAR. ITAR defines a U.S. person as a U.S. Citizen, U.S. Permanent Resident (i.e. Green Card Holder), Political Asylee or Refugee. The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

Apply here!

Here at Trelleborg Sealing Solutions, in Rotherham, we are proud to manufacture Orkot® bearings and wear rings. Orkot® is the world's leading brand in composite bearing material for wear resistant bearings under high load. With over 60 years’ experience in composite bearings, our Rotherham facility provides a full service, from engineering concept to delivery of a bearing solution for specialist markets such as marine, hydro & tidal power.

We have a full time, vacancy for a Senior Quality Inspector at our Centre of excellence site in Rotherham, South Yorkshire, United Kingdom.

Hours of work

The hours of working Monday to Thursday 7.30am to 4pm and Friday 6am until 12pm (38 hours per week) 

What be you’ll doing?

Your role is essential to our organization. Reporting to the Quality Manager, the Senior Quality Inspector will support the implementation, maintenance and ensure the applicability of the Integrated Management System in alignment with ISO9001:2015 and AS9100.

You will possess the appropriate quality and technical skills to be an expert in your subject matter. In doing so, facilitate problem solving techniques / guiding / coaching and taking the appropriate action(s) to support the organization in resolving Quality related issues.

As the Senior Quality Inspector, your role will entail:

Mentoring and supporting two Quality Inspectors in their development and sharing of expertise.

Assisting with third party audits and assessments, control principles such as calibration system,

Supporting FAIR and ISIR processes, coordinating and assisting with internal and external concerns, corrective action investigations and reports.

Supporting and assisting with site continuous improvement projects as identified by Quality Manager. 

Supporting the handling of customer returns, ensuring all returns whilst working with the Quality Manager to help identify relevant information in a timely manner.

Interacting with other departments to support production activities as applicable.

Developing and maintaining company inspection reports

Completing Quality Audits, reports and documentation required by external bodies (Green passports, FAIRs, ISIR, Military body reports, photographic reports etc..)

Working with all internal departments to drive and maintain quality levels, assist and support investigations into root-cause and assist in issue resolution.

Liaising with customers to help resolve queries and communicate information in relation to inspection and reporting.

Creating maintaining and revising specialized quality documentation.

Assisting with the process for dealing with and resolving non-conforming product.

Sharing knowledge and skills with other departments offering help and support where required and helping operators/ other departments within process inspection and queries.

What we need from you?

To be successful in this role, you will:

• Have technical competence within Engineering, preferably educated to degree level or time served experience of role.
• Hold a recognized Quality qualification or equivalent would be beneficial but not essential.
• Have experience of recognized Quality Systems (AS9100/ISO9000/).
• Be able to apply sound analytical techniques and have good verbal and written communication skills

• Be self-motivated and able to work on own initiative for prolonged periods without supervision.
• 
  
• Be able to read technical drawings.

• Have previous of Aerospace, automative or marine industries
• Possess experience of producing and collating FAIRS and associated documents - this would be beneficial but not essential as training can be given.

Along with the above education and experience, the following personal qualities make you an ideal candidate!

• You have a progressive ‘can-do’ attitude, with a willingness to learn and a keenness towards problem solving.
• You can work quickly and methodically whilst possessing a high standard of attention to detail
• You are hardworking, reliable, and possesses excellent communication & interpersonal skills.
• Comfortable with multi-tasking, prioritizing workload and achieving work to strict deadlines.
• Have the ability to develop and sustain good relationships with a range of internal and external stakeholders.
• Be self-motivating and able to work with minimum supervision when required
• Well organised, possess great time management skills. Able to meet deadlines
• Good leadership and stakeholder influencing skills
• Have previous knowledge of manufacturing processes
• Possess strong analytical and problem-solving skills
• Be able to exercise good judgment and make timely decisions
• You are passionate about continuous improvement and playing a key role in driving the department forward.
• You hold and demonstrate high work ethics
• You have the ability and like to use your own initiative, 
• Have a preference for working as part of a team.

We offer great benefits in return: 

• An attractive and competitive salary
• A non-contractual bonus, linked to organizational performance.
• Flexible on-site working.
• Holiday entitlement of 25 days per, plus bank holidays.
• Group pension scheme
• Life assurance scheme (4x annual salary)
• Employee assistance program with remote GP, nutrition and well-being app, physio and counselling support
• Christmas Hamper/ Easter Gifts and various well-being incentives
• Free fruit & hot drink vending
• Mental Health First Aiders

In accordance with the Home Office guidance, successful candidates will be required to evidence their right to work in the United Kingdom before commencement of employment. Potential candidates will therefore be asked to demonstrate their right to work status for the UK, at the first interview.

We are an Equal Opportunity Employer, and we take pride in the diversity of our employees, valuing the special experience and expertise that people from different backgrounds bring to our business. The ability to develop ground-breaking technologies is one of our key assets and our people make it happen.

Our people are shaping industry from the inside. If you have the relevant experience and are excited about this opportunity, we’d love to hear from you! 

Gehen Sie neue Herausforderungen mit Leidenschaft an und übernehmen Sie Verantwortung für Ihr Handeln?

Seien Sie der Wandel, den Sie sehen möchten, und gestalten Sie die Branche von innen heraus mit.

Wer sind wir?

Trelleborg Industrial Solutions (TIS) ist ein weltweit führender Anbieter innovativer polymerbasierter Lösungen für Schlüsselindustrien und kritische Infrastrukturen.

Wir sind einer von drei Geschäftsbereichen innerhalb der Trelleborg-Gruppe und beschäftigen weltweit ca. 6.200 Mitarbeiter.

Über die Stelle

Als Qualitätsingenieur (m/w/d) spielen Sie eine Schlüsselrolle bei der Sicherstellung der Lieferantenleistung, der Produktqualität und der Einhaltung internationaler Standards. Zu Ihren Aufgaben gehören die Qualifizierung und Entwicklung von Lieferanten, die Durchführung interner und externer Audits sowie die Verwaltung des integrierten Managementsystems gemäß der DIN Normen ISO 9001, 14001, 45001, 50001 und ISO/TS 22163. Sie überwachen Lieferantenbewertungen, Erstmusterfreigaben und Korrekturmaßnahmen und sorgen gleichzeitig für eine enge Zusammenarbeit zwischen den Abteilungen Einkauf, Entwicklung und Qualität.

In dieser Funktion wenden Sie Ihr technisches Fachwissen in mechanischen oder metallverarbeitenden Prozessen wie Gießen, Schmieden, Schweißen und Beschichten an, um eine kontinuierliche Verbesserung entlang der gesamten Lieferkette voranzutreiben. Sie überwachen Qualitätsziele anhand von Kennzahlen und Dashboards, tragen zu Produktentwicklungsaktivitäten wie FMEA und EMPB bei und stellen sicher, dass alle Prozesse die Compliance- und Leistungserwartungen erfüllen. Dies ist eine dynamische Position, die ausgeprägte analytische Fähigkeiten, eine proaktive Denkweise und die Bereitschaft zu ausgiebigen Reisen erfordert, um Lieferanten und interne Stakeholder zu unterstützen.

Ihre Aufgaben

• Qualifizierung und Weiterentwicklung von Lieferanten
• Lieferanten- und Prozessaudits
• Verantwortlich für die Durchführung und Planung der erforderlichen internen und externen Audits
• Verwaltung des integrierten Managementsystems einschließlich Dokumentenmanagement gemäß ISO 9001 / 14001 / 45001 / 50001 sowie ISO/TS 22163
• Verantwortung für die Aufrechterhaltung der Normkonformität des Systems und dessen Weiterentwicklung
• Erstbemusterung bei Lieferanten und deren Freigabe / Ablehnung
• Nachverfolgung von Beanstandungen und Korrekturmaßnahmen aufgrund von Audits oder anderen Abweichungen
• Erstellung von Audit-, Besuchs- und Kennzahlenberichten
• Bewertung von Lieferanten gemeinsam mit der Einkaufsabteilung
• Schnittstelle zwischen Einkaufs- und Qualitätsabteilung und dem Lieferanten
• Effiziente und effektive Anwendung von Qualitätstechniken
• Unterstützung bei der Kontrolle relevanter Qualitätsziele und Leistungskennzahlen; inkl. Verwaltung eines Qualitäts-Dashboards
• Mitwirkung am Produktentwicklungsprozess (z. B. FMEA, PLP, QPA, EMPB) in direkter Abstimmung mit Einkauf und Entwicklung.

Ausbildung und Erfahrung

• Technischer Hochschulabschluss oder abgeschlossene Berufsausbildung, mehrjährige Berufserfahrung und Qualifikationen im Qualitätsmanagement
• Umgang mit Lieferanten und Kunden
• Kenntnisse im Maschinenbau und/oder in der Metallverarbeitung
• Erfahrung und Kenntnisse in speziellen Verfahren (Gießen, Schmieden, Schweißen, Beschichten)
• Fähigkeit zum Lesen von Zeichnungen, gutes technisches Verständnis von Produkten und Prozessen
• Grundlagen der Betriebswirtschaft
• Fundierte Kenntnisse der Normen ISO 9001 / ISO 14001
• Kenntnisse der Normen IAFT 16949 oder ISO/TS 22163 sind von Vorteil
• Kenntnisse und Erfahrungen in der Planung, Durchführung und Bewertung von Audits und Erstmustern
• Bereitschaft zu umfangreichen Reisetätigkeiten ist Voraussetzung

Unser Angebot und Ihre Vorteile

• Eine verantwortungsvolle und ergebnisorientierte Aufgabe in einem international tätigen Industrieunternehmen
• Wir bieten ein motivierendes Umfeld, das Ihnen Wachstum innerhalb des Unternehmens ermöglicht, und investieren in Ihre Aus- und Weiterbildung
• Familiäre und angenehme Arbeitsatmosphäre mit moderner Ausstattung
• Attraktives, wettbewerbsfähiges Vergütungspaket
• 30 Tage Jahresurlaub

Bewerbungsverfahren

Klingt das nach dem idealen Umfeld für Sie?

Zögern Sie nicht und bewerben Sie sich jetzt, um Ihre Karriere bei Trelleborg zu gestalten. Bewerben Sie sich jetzt mit einer englischen Version Ihres Lebenslaufs.

Trelleborg ist ein Arbeitgeber, der Chancengleichheit fördert, und wir sind stolz auf die Vielfalt unserer Mitarbeiter. Wir schätzen die besonderen Erfahrungen und Fachkenntnisse, die Menschen mit unterschiedlichem Hintergrund in unser Unternehmen einbringen. Die Fähigkeit, bahnbrechende Technologien zu entwickeln, ist einer unserer wichtigsten Vorteile, und unsere Mitarbeiter machen dies möglich.

Wir bieten ein motivierendes Umfeld, das Wachstum innerhalb des Unternehmens ermöglicht und gleichzeitig in die Aus- und Weiterbildung unserer Mitarbeiter investiert.

Wir begrüßen Bewerbungen von Menschen aller Nationalitäten, Religionen, Geschlechter, sexuellen Identitäten, unterschiedlichen Alters und mit Behinderungen.

Bei Trelleborg gestalten unsere Mitarbeiter die Industrie von innen heraus (#shapingindustryfromtheinside).

About the job

As a Quality Engineer, you will play a key role in ensuring supplier performance, product quality, and compliance with international standards. Your responsibilities will include qualifying and developing suppliers, conducting internal and external audits, and managing the integrated management system across ISO 9001, 14001, 45001, 50001, and ISO/TS 22163 frameworks. You will oversee supplier evaluations, initial sample approvals, and corrective actions while maintaining strong collaboration between purchasing, development, and quality departments.

In this role, you’ll apply your technical expertise in mechanical or metalworking processes such as casting, forging, welding, and coating to drive continuous improvement across the supply chain. You’ll monitor quality targets through metrics and dashboards, contribute to product development activities like FMEA and EMPB, and ensure all processes meet compliance and performance expectations. This is a dynamic role that requires strong analytical ability, a proactive mindset, and willingness to travel extensively to support suppliers and internal stakeholders.

Your Responsibilities

• Qualification and further development of suppliers
• Supplier and process auditing
• Responsible for the implementation and scheduling of the necessary internal and external audits
• Management of the integrated management system including document management according to ISO 9001 / 14001 / 45001 / 50001, as well as ISO/TS 22163
• Responsible for maintaining the standard conformity of the system and its further development
• Initial sampling at suppliers and their approval / rejection
• Follow-up of complaints and corrective measures due to audits or other deviations
• Preparation of audit, visit and key figure reports
• Evaluating suppliers together with the purchasing department
• Interface between the purchasing and quality department and the supplier
• Efficient and effective use of quality techniques
• Support in the control of relevant quality targets and performance metrics; incl. management of a quality dashboard
• Participation in the product development process (e.g. FMEA, PLP, QPA, EMPB) in direct coordination with Purchasing and Development.

Education and Experience

• Technical university degree or completed vocational training, several years of professional experience and qualifications in quality management
• Dealing with suppliers and customers
• Knowledge of mechanical engineering and/or metalworking
• Experience and knowledge of special processes (casting, forging, welding, coating)
• Ability to read drawings, good technical understanding of products and processes
• Fundamentals of business administration
• In-depth knowledge of ISO 9001 / ISO 14001
• Knowledge of IAFT 16949 or ISO/TS 22163 is an advantage
• Knowledge and experience in planning, conducting, and evaluating audits and initial samples
• Willingness to travel extensively is a prerequisite

Our Offer and Benefits

• A responsible and results-oriented task in an internationally active industrial company
• We provide an encouraging environment offering growth within the company while investing in your training/education
• Family and congenial working atmosphere with modern equipment
• Attractive competitive compensation package
• Generous annual leave 

Application Process

Trelleborg is an Equal Opportunity Employer, and we take pride in the diversity of our employees, valuing the special experience and expertise that people from different backgrounds bring to our business. The ability to develop ground-breaking technologies is one of our key assets and our people make it happen.

We provide an encouraging environment which offers growth within the company while investing in employee training/education. Our facility is a close and friendly community which allows you to brainstorm your ideas with other colleges.

We encourage applications from people of all nationalities, religions, genders, sexual identities, different ages and people with disabilities.

At Trelleborg our people are #shapingindustryfromtheinside

Trelleborg Medical Solutions is seeking a Quality Engineer to join their team. Responsible for the development and administration of a Quality System compliant to FDA and ISO requirements, including the utilization of optimal, cost-effective lean manufacturing processes and methods for new and existing projects including inspection, test and label control operations.  Working with internal and external customers supports, quality and continuous improvement using appropriate tools, project leadership.

Responsibilities:

• Supports internal audit program as necessary.
• Supports customer complaint (CC) and RMA system per procedures. Performs investigations, supports determination of the disposition of returned goods, determines re-inspection requirements, determines corrective and preventive actions (CAPA), issues complaint reports, supports completion of customer CAPAs, and approves to close. Looks for trends to determine actions to decrease number of CCs
• Maintains Non-Conforming (NC) system per procedures. Performs investigations, participates in MRB (Material Review Board) activities, supports determination of the disposition, determines re-inspection requirement, supports determination of corrections/corrective actions and approves to close. Looks for trends to decrease number of NCs and provide feedback to management
• Maintains corrective and preventive action (CAPA) system per procedures. Initiates and performs root cause analysis. Uses statistical and capability analysis to solve problems. Implements and verifies CAPAs
• Performs trend analysis of CAPA, NCM, Complaint/Customer Feedback, Risk Management activities, Audits, etc. and presents periodic reports for management review. Assesses Design and any associated activities for manufacturability.
• Adheres to the company’s Quality System (QS), writes and approves QS documents
• Authors and executes Quality Plans for Quality Management Systems and Organizational Objectives projects.
• Support Engineering, Manufacturing, and Inspection personnel in design, methods, tooling, validations, and other areas related to the control of product quality.
• Communicates with customers on complaints, process changes, clarification of specifications, completing customer documents, and other projects as needed
• Conducts studies including Gauge R&R’s to develop inspection methods and test equipment. Creates measurement system programs, when necessary.
• Establishes inspections and sampling procedures to ensure the control of quality at the most economical costs.
• Creates, reviews and approves Equipment Qualifications, Process, Cleaning, and Software Validation, pFMEA and other documentation as necessary.
• Participates in customer and ISO audits.

Qualifications:

Required:
• 4 year degree in quality, engineering or  related field

Desired:
• 2+ years in a manufacturing environment in a technical support role
• ASQ Certified Quality Engineer
• Formal Six Sigma Yellow/ Green belt training

As a valued team member with Trelleborg, you will enjoy:

Competitive compensation: Plus, bonus opportunities!
Generous benefits package: Includes health, dental, vision, STD, LTD, life, 401k, paid time off, tuition reimbursement, and more!
Clean work environment: Enjoy working in a very clean and climate-controlled environment every day!
Greater opportunity for impact: You will impact the production of life-saving devices.
Growth and advancement: Join a global company that loves to promote from within and allows for advancement.

Salary information:  $72-91k based on experience 

Apply here!

• Ensuring that risk assessment is carried out in all departments, making recommendations on the measures to be taken and monitoring them
• To inspect the field and employees and report the detected nonconformities, determine corrective actions, make suggestions regarding the activities and ensure follow-up of the actions
• To investigate the causes of occupational accidents and occupational diseases that occur in the workplace and to carry out studies on the measures to be taken to prevent their recurrence
• To conduct studies on the causes of incidents that occur in the workplace but do not cause death or injury, but have the potential to harm employees, equipment or the workplace
• Making necessary checks and approving works that require work permits
• Updating emergency plans, participating in training and drills
• To carry out machine commissioning, to report detected non-conformities, to determine corrective actions, to make suggestions regarding activities and to ensure follow-up of actions
• Following and reporting legal compliance
• To provide occupational health and safety training to employees in accordance with the relevant legislation
• Processing HSE data into the system and making reports
• Entering HSE KPIs into the system and following the actions

• Graduating from university engineering faculties or Occupational Health and Safety departments
• Preferably having at least 3 years of experience in a similar position in industrial production companies
• Having at least a Class B Occupational Safety Expertise Certificate
• To be familiar with the Occupational Health and Safety Law No. 6331 and its related regulations, the Environmental Law No. 2872 and its related regulations
• Being experienced in field applications
• To have developed problem solving skills theoretically and practically
• Being able to use Microsoft Office programs
• Having a good command of English
• Being able to drive actively
• No restrictions on domestic or international travel

  Service Routes

  Gebze: We provide service to every region except Şekerpınar.
  Izmit: It can be any region on the E-5 between Gebze and Izmit (Central). The service goes via E-5.

  Istanbul 
  Service 1: Göztepe-Küçükyalı-Yakacık-Sultanbeyli-Kurtköy-Factory (via E-5)
  Service 2: Küçükyalı-Kartal-Pendik-Esenyalı-Tuzla-Factory (via E-5)

Tasks and Responsibilities

• Supports all aspects of the internal audit program, ISO notified body audits, customer audits and FDA inspections, including but not limited to:
  • Serve as an auditor for internal audits
  • Create and maintain internal audit schedule
  • Audit controlled document files in preparation for regulatory inspections and provides support during regulatory inspections and client audits
  • Initiate and execute audits, including developing and documenting the audit plan, leading the audit, generating the audit report, and tracking subsequent actions with the team
  • Provide support during external audits including scheduling, hosting, preparing audit responses
  • Work with subject matter experts to ensure audit record content is accurate, well documented, and meets the requirement of the process
• Develops metrics and performs trend analysis of key QS areas such internal and

 external audit findings, CAPAs, nonconforming material, training, deviations, etc. to identify areas for improvement. Escalates trends to an appropriate quality system such as CAPA or CI; presents analysis to management

• Supports maintenance of the CAPA program
  • Serves as CAPA Owner as needed, driving necessary investigation, correction, and corrective/preventive actions
  • Ensures all internal and external audit findings are entered into the CAPA system, assigned to the appropriate personnel, and are completed in accordance to the CAPA procedures, within specified time periods
  • Approve corrective action plans and verify effective and timely implementation of corrective actions for audit nonconformities
• Oversees completion and control of customer questionnaires and other customer-required documents
• Initiates, facilitates and/or manages projects to expand, change, enhance and improve the quality system, as assigned
• Supports and coordinates activities related to nonconforming material, complaint/customer feedback, deviations, RMA, and CAPA processes
• Provides quality system training for the organization as needed
• Manages review of documents to ensure ISO/FDA compliance of controlled documents lifecycle including annual review management
• Ensures all work is performed and documented in accordance with GMP requirements and existing company policies and procedures
• Other duties as assigned

Education and Experience

Required

• Minimum of 2 year degree in Quality, Regulatory, Manufacturing or related field; OR certificate in Regulatory Science or Medical Product Development plus 1 year of regulated industry work experience

Desired

• 4 year degree in Quality, Regulatory, Manufacturing or related field
• ISO13485:2016 and/or ISO9001:2015 Auditor Certification
• Knowledge and experience with GMP/ISO Standards: ISO 9000/9001, ISO 13485, and FDA 21CFR 820/11 (4/210/211 as applicable)
• 3+ years of quality/regulatory experience in medical device or related industry
• 1 year experience conducting investigations and root cause analysis for complex/advanced issues

Competencies

• Ability to read, write, speak and understand the English language
• Ability to communicate clearly by conveying and receiving ideas, information and direction effectively
• Ability to demonstrate adequate job knowledge to deliver a world class performance
• Ability to challenge oneself to consistently meet all goals and deadlines
• Willingness to strive for excellence by producing work that is free of errors and mistakes
• Desire to delight both customers and coworkers by offering encouragement, fostering teamwork and addressing conflict appropriately
• Commitment to making improvements company wide
• Demonstrated competence using Microsoft Office
• Comprehensive understanding of applicable cGMP requirements, including ISO standards, and FDA and other QS regulations
• Comprehensive understanding of internal documentation (e.g., QS Manual, SOPs, etc.) and records and how they relate to cGMP requirements
• Knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques
• Experience with metrics development and data analysis
• Able to provide compliance guidance based on knowledge of regulations, available relevant information, alternatives, and risk
• Able to perform math functions
• Effective trainer and project leader
• Good hand/eye coordination and depth perception
• Good manual dexterity
• Ability to maintain a professional and respectful relationship with coworkers and company representatives

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran, disability, or any other status protected by state or federal law.

NOTE:  This job description is not intended to be all-inclusive. Employees may perform other related duties as required to meet the ongoing needs of the organization.

At Trelleborg our people are #shapingindustryfromtheinside 

Apply here!

Summary of the Role: 

Inspectors will verify the product coming in and the product going out determining if they meet customer requirements.

Tasks and Responsibilities: 

• Inbound Inspection

• Outbound inspection
• Acquire supporting documentation for orders
• Other duties as assigned

Education and Experience: 

• Associates degree preferred, HS diploma or GED required.
• Minimum 1 year experience in Quality inspection required.
• Basic blueprint reading skills required

Competencies: 

• Strong interpersonal and communication skills.
• Basic computer skills
• Basic reading skills
• Basic arithmetic skills
• Time management skills including meeting deadlines for OTD.
• Ability to successfully work independently

Travel:

• Local coverage 
• Travel for off site training when required, 5%

Benefits include:

401(k) matching
Dental insurance
Disability insurance
Employee assistance program
Flexible spending account
Health insurance
Health savings account
Life insurance
Paid time off
Tuition reimbursement

Application: 

Apply here!

Last Application Date 12/13/2025

As an EEO/Affirmative Action Employer all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran or disability status.

This position requires the use of information which is subject to the International Traffic in Arms Regulations (ITAR). All applicants must be U.S. persons within the meaning of ITAR.  ITAR defines a U.S. person as a U.S. Citizen, U.S. Permanent Resident (i.e. Green Card Holder), Political Asylee or Refugee

Er du positiv, udviklingsparat, kvalitetsbevidst til fingerspidserne og har gode samarbejdsevner? Så er det måske dig, vi mangler til den ledige stilling som QC-medarbejder til nathold!

Vi er 285 engagerede kolleger hos Trelleborg Sealing Solutions i Helsingør, og vi er specialiserede i udvikling og produktion af tætningssystemer til højteknologiske virksomheder inden for hydraulik-, bil-, fly-, skibs-, olie- og maskinindustrien. Selvom vi måske ikke er så kendte i den brede befolkning, er vi blandt verdens bedste inden for vores felt, og vi anerkendes af vores kunder for vores produkter og kvalitet. Det opnår vi ved konstant at stille krav til hinanden, til vores leverandører og ikke mindst til vores produkter. Vi er en del af den børsnoterede Trelleborg Group, som har knap 17.000 medarbejdere fordelt over hele verden.

Hvad går stillingen ud på?

I rollen som Quality Control (QC)-medarbejder er det ikke et krav, at du har erfaring fra en lignende stilling, men det er naturligvis en fordel. Det er dog et krav, at du efter grundig oplæring kan være nogenlunde selvkørende og arbejde selvstændigt. Det er altafgørende, at du aldrig går på kompromis med kvaliteten, og at du altid hellere tjekker en gang for meget end en gang for lidt. QC har en bred kontaktflade, og du skal derfor trives i en udadvendt rolle samt være god til at samarbejde og kommunikere med kolleger på tværs af afdelinger.

Dine primære opgaver vil indebære:

• Stikprøvekontrol af emner i alle størrelser og godkendelse af færdige produkter
• Kontrol af Notch, Cut og afsyrede produkter
• Assistere produktionen med måleteknik m.m.
• Diverse QC-opgaver

Arbejdstider:
Dine arbejdstider vil ligge i tidsrummet mandag-torsdag fra kl. 22:35 til kl. 07:05. Du skal dog være indstillet på, at din oplæring kan foregå på enten dag- eller aftenhold.

Hvem er du?

For os er det ikke afgørende, hvad du tidligere har arbejdet med, eller hvilken uddannelsesmæssig baggrund du har – vi tror nemlig på, at hvis man har evnerne og den rette indstilling, vilje og gå-på-mod, så kan resten tillæres. Derfor lægger vi vægt på, at du:

• Er grundig, kvalitetsbevidst og tager ejerskab over dine opgaver
• Kan håndtere afbrydelser og pludselige spørgsmål i din arbejdsgang uden at miste fokus
• Bidrager positivt til fællesskabet med godt humør og ser muligheder fremfor begrænsninger
• Kan begå dig på dansk i skrift og tale

Hvad kan vi tilbyde dig?

Vi kan tilbyde dig at blive en del af Trelleborg Sealing Solutions, hvor vi får biler til at yde mere, fly til at lande stabilt og gravkoen til at bryde igennem det umulige. Derudover kan du se frem til:

• En arbejdsplads med højt humør, godt sammenhold og en uformel tone
• Erfaring fra en virksomhed med anerkendte produkter og høje kvalitetsstandarder
• Personale- og idrætsforening, sundhedsforsikring, kunstforening og en helt fantastisk kantineordning

Skal du være med på holdet?

Så vil vi glæde os til at modtage din ansøgning og CV senest den 30. november 2025 via formularen nedenfor.

Vi holder samtaler løbende, så send meget gerne din ansøgning allerede i dag.

Har du spørgsmål til stillingen, er du velkommen til at kontakte teamleder i QC, Katrine Dreyer, på telefon 49 27 02 40.

Hos Trelleborg Sealing Solutions behandler vi alle lige. Vi værdsætter diversitet og sætter en ære i at skabe et inkluderende miljø for alle medarbejdere. Vi opfordrer alle, uanset køn, alder, nationalitet, religiøs overbevisning, identitet og demografisk baggrund, til at ansøge.

Imagine leveraging your quality expertise while working for one of the leading contract manufacturers in the world. Seize this rare opportunity to be part of a healthcare and medical business unit with the support and stability of an organization that has been in business for over 100 years.

Trelleborg Medical Solutions is seeking a NPD Quality Engineer to join their team. The NPD Quality Engineer is responsible to plan and coordinate quality assurance activities for medical device manufacturing through the design and development phases including validation for new product development. Collaborate with New Product Development (NPD) teams to support equipment qualification, software validation, test method development/validation, process development/validation (IQ/OQ/PQ), and other quality processes to ensure compliance with the company's Quality System and applicable external requirements and standards, including FDA, ISO 13485, and/or other regulatory agencies as applicable to medical device manufacturing. Working with internal and external customers to support creative approaches and solutions to problems.

Tasks and Responsibilities:

• In conjunction with the NPD team, plan, develop and execute equipment, software, test method, and/or process validation strategy
• Perform risk management by identifying, estimating, evaluating, controlling, and monitoring risk, utilizing risk tools such as Process Failure Modes and Effects Analysis (pFMEA)
• Author or approve protocols and reports for Equipment Qualification (IQ/EQ), Software validation (SV), Test Method Validation (TMV), Process validation (OQ/PQ)
• Review and evaluate specifications, drawings, quality agreements, customer documentation and other documents as necessary to support NPD projects
• Plan, coordinate, and oversee Test Method Development and Validation activities, initiate inspection plans for new/revised product
• Develop test methods or work with the Metrology team to recommend equipment, sampling plans, and measurement techniques for inspection specifications
• Perform measurement system analysis (MSA) Gage 1, Gage Repeatability and Reproducibility (GRR), Bias and Linearity, Resolution and Stability studies
• Perform statistical analysis of inspection data, process characterization, design of experiments (DOE) results, ANOVA, Capability Analysis
• Author and execute Quality Plans for Quality Management Systems and Organizational Objectives projects
• Initiate and perform root cause analysis, using statistical and capability analysis to solve problems
• Adhere to the company’s Quality System (QS), write, and approve QS documents
• Review and ensure compliance with QMS of all validation documents and records
• Support Engineering, Manufacturing, and Inspection personnel in design, methods, tooling, validations, and other areas related to the control of product
• Communicate with customers on clarification of specifications, completing customer documents, complaints, process changes, and other projects as needed
• Understand regulatory requirements (e.g. ISO13485, 9001, 14971, FDA 21 CFR 820, ITAR)
• Provide periodic work direction and assistance to QA inspectors, QA technicians and Quality Engineering Technicians
• Support other quality activities as necessary such as customer complaint (CC) and RMA system per procedures, corrective and preventive actions (CAPA),
• Support internal and external audits
• Other duties as assigned

Education and Experience

Required:

• 4 year degree in quality, engineering or any related field
• 5+ years in a manufacturing environment in a technical support role
• Knowledge and experience with GMP/ISO Standards

Desired:
• Certified Six Sigma Yellow/Green
• ASQ Certified Quality Engineer and/or Auditor
• Class I, II, and/or III Medical device manufacturing experience

Competencies

• Ability to read, write, speak and understand the English language (with a translator, if necessary)
• Ability to communicate clearly by conveying and receiving ideas, information and direction effectively
• Desire to delight both customers and coworkers by offering encouragement, fostering teamwork and addressing conflict appropriately
• Demonstrated competence using Microsoft Office, Project, Access and JMP
• Comprehensive understanding of applicable Work Instructions, SOPs, and ISO standards
• Working knowledge of statistical methods associated with six sigma and quality control.
• Able to perform math functions
• Effective project leader
• Experience with lean manufacturing principles and their implementation
• Good hand/eye coordination and depth perception
• Good manual dexterity
• Correctable normal reading distance vision

As a valued team member with Trelleborg, you will enjoy:

Competitive compensation: Plus, bonus opportunities!
Generous benefits package: Includes health, dental, vision, STD, LTD, life, 401k, paid time off, tuition reimbursement, and more!
Clean work environment: Enjoy working in a very clean and climate-controlled environment every day!
Greater opportunity for impact: You will impact the production of life-saving devices.
Growth and advancement: Join a global company that loves to promote from within and allows for advancement.

Salary range: $90,000-115,000/year

NOTE: This job description is not intended to be all-inclusive. Employees may perform other related duties as required to meet the ongoing needs of the organization.

EEO Statement

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran, disability, or any other status protected by state or federal law.

Apply here!

Imagine leveraging your quality mgmt expertise while working for one of the leading contract manufacturers in the world. Seize this rare opportunity to be part of a healthcare and medical business unit with the support and stability of an organization that has been in business for over 100 years.

Trelleborg Medical Solutions is seeking a NPD Quality Manager to join their team. The NPD Quality Manager develops and achieves New Product Development (NPD) Quality initiatives to support Trelleborg Goals and Objectives. Oversees the Validation and verification requirements of new products/programs as well as ensuring that all related quality activities are carried out in accordance with industry standards and regulations. Manages overall NPD Quality resources and ensures that capacity and capability meet the customer demand. Optimizes both human and capital resources through continuous improvement activities.

Tasks and Responsibilities

• Provides leadership for NPD Quality Team within the Innovation Center or remotely located at an H & M Manufacturing site, with varying degrees of expertise and experience
• Manages & oversees all aspects of the H&M NPD Quality Team (multiple sites) involved in quality related product/program development projects from conceptualization & validation phase through release to manufacturing
• Must be knowledgeable and adhere to H&M Trelleborg Quality Management System and its requirements
• Drives and supports QMS initiatives and continuous improvement activities.
• Ensures direct reports are successfully performing their duties as assigned. Provides coaching on an ongoing basis.
• Assigns projects and responsibilities to the direct reports. Ensures skill-sets of staff are in alignment with expected duties.
• Establishes and develops site-specific processes as required/requested
• Reviews and approves processes, Quality Plans, protocols/reports, as necessary.
• Ensures proper resource allocation to support needs to ensure delivery expectations of customers
• Provides recommendations for goals and objectives for the Quality Department
• Works closely with internal resources to establish processes and resolve issues
• Drives best practices through the application of effective quality engineering principals and procedures across functions
• Ensures proper controls are being systematically applied to both new and legacy products
• Supports internal and external audits
• Provides recommendations based on data for improvements that are measurable.

Education and Experience

Required:

• 4-year degree in Engineering or Science-related field
• 6 years of increasing experience providing technical support and leadership in medical device manufacturing environment
• 2 years Leadership/Supervisory-level experience, with decision-making authority/responsibility
• Quality certifications (ASQ CQE, CQA, CQM, etc.)
• Class I, II, III Medical Device Manufacturing experience
• Knowledge and experience with ISO/FDA: ISO 9000/9001; ISO 13485, and 21CFR Part 11/820 (and 4/210/211 as applicable)

Desired

• Experience in coaching and utilizing performance management tools and disciplines
• Experience in a CMO producing Medical Devices
• Experience with ERP, Document Control, MES, and other types of software
• Experience auditing (internal and external) for all elements of ISO 9001 and/or ISO 13485
• Experience with the successful completion of multiple projects for new product development or improvement initiatives
• Extensive experience with statistical analysis, Minitab software (or equivalent), GD&T and CAPA investigation and resolution

Competencies

• Ability to read, write, speak and understand the English language
• Ability to communicate clearly by conveying and receiving ideas, information and direction effectively
• Ability to demonstrate adequate job knowledge to deliver a world class performance
• Ability to challenge oneself to consistently meet all goals and deadlines
• Willingness to strive for excellence by producing work that is free of errors and mistakes
• Demonstrated active leadership skills
• Demonstrated ability to lead projects and get results through others
• Ability to manage tasks with competing priorities and deadlines
• Proven team building skills
• Strong statistical background and understanding
• Ability to lead cross functional groups for continuous improvement projects
• Ability to apply Six Sigma Methodologies to manufacturing processes and experience teaching others these techniques
• Strong verbal, written, organizational and interpersonal skills. Ability to communicate clearly and effectively to customers either in person or via video or telephone conference
• Ability to work flexible schedule as required by workload/project

As a valued team member with Trelleborg, you will enjoy:

Competitive compensation: Plus, bonus opportunities!
Generous benefits package: Includes health, dental, vision, STD, LTD, life, 401k, paid time off, tuition reimbursement, and more!
Clean work environment: Enjoy working in a very clean and climate-controlled environment every day!
Greater opportunity for impact: You will impact the production of life-saving devices.
Growth and advancement: Join a global company that loves to promote from within and allows for advancement.

Salary range: $109,000-125,000/year

NOTE: This job description is not intended to be all-inclusive. Employees may perform other related duties as required to meet the ongoing needs of the organization.

EEO Statement

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran, disability, or any other status protected by state or federal law.

Apply here!

About the job

The Quality Manager plays a pivotal role in ensuring adherence to stringent quality standards and continuous improvement initiatives. Responsible for overseeing and implementing robust quality control processes, the Quality Manager is integral to maintaining the highest levels of product excellence and customer satisfaction.

Your Responsibilities

• Quality Control Oversight:
  • Implement and manage comprehensive quality control processes.
• Compliance Management:
  • Ensure adherence to industry regulations, certifications, and quality standards.
• Supplier Quality Management:
  • Collaborate with suppliers to establish and maintain rigorous quality standards.
• Quality Assurance Planning:
  • Develop and implement quality assurance plans, to guarantee reliability.
• Root Cause Analysis:
  • Investigate and identify root causes of quality issues, implementing corrective and preventive actions to eliminate recurring problems.
• Data Analysis and Reporting:
  • Utilize statistical methods and data analysis tools to track key quality metrics.
• Cross-functional Collaboration:
  • Collaborate with other departments to approach quality management and problem resolution.
• Risk Management:
  • Identify potential quality risks and develop strategies to mitigate them.
• Continuous Improvement:
  • Foster a culture of continuous improvement.
• Documentation and Record Keeping:
  • Maintain accurate and comprehensive records of quality activities.
• Auditing and Assessment:
  • Conduct regular internal audits to evaluate compliance with quality management systems and initiate corrective actions as needed.
• New Product Introduction (NPI):
  • Collaborate with product development teams to ensure that new products meet established quality standards.
• Quality Management System (QMS) Maintenance:
  • Oversee the development, implementation, and maintenance of a robust Quality Management System.
• Emergency Response Planning:
  • Develop and implement plans for responding to quality emergencies or recalls.
• Communication:
  • Effectively communicate quality objectives, expectations, and performance metrics to all levels of the organization.

Education and Experience

• Bachelor's degree in a relevant field such as engineering, quality management, industrial management, or a related
  discipline.
• Proven experience in quality management roles within a manufacturing environment.
• Demonstrated success in implementing and maintaining quality management systems.
• Certification in quality management systems, such as Certified Manager of Quality/Organizational Excellence (CMQ/OE) or similar, can be beneficial.

Competencies

• Strong leadership skills, with the ability to inspire and guide teams.
• Excellent problem-solving and analytical abilities to drive effective decisions.
• Solid knowledge of auditing, compliance, and health & safety regulations.
• Proven project management skills, delivering results on time and within scope.
• Strong customer focus, building trust and long-term relationships.
• Deep industry knowledge with a commitment to maintaining high ethical standards.
• A continuous improvement mindset, always seeking smarter and more efficient ways of working.

Our Offer and Benefits

• A responsible and results-oriented task in an internationally active industrial company
• We provide an encouraging environment offering growth within the company while investing in your training/education
• Family and congenial working atmosphere with modern equipment
• Very attractive competitive compensation package
• Generous annual leave 

Application Process

Trelleborg is an Equal Opportunity Employer, and we take pride in the diversity of our employees, valuing the special experience and expertise that people from different backgrounds bring to our business. The ability to develop ground-breaking technologies is one of our key assets and our people make it happen.

We provide an encouraging environment which offers growth within the company while investing in employee training/education. Our facility is a close and friendly community which allows you to brainstorm your ideas with other colleges.

We encourage applications from people of all nationalities, religions, genders, sexual identities, different ages and people with disabilities.

At Trelleborg our people are #shapingindustryfromtheinside

At Trelleborg Sealing Solutions, we are seeking a Quality Planner for Initial Sampling to join our dynamic team! This outstanding role places you at the forefront of ensuring our products meet world-class standards from the very first sample. If you demonstrate attention to detail and a dedication to quality, this is the perfect opportunity for you to excel in an ambitious and collaborative environment.

🎯 Your Responsibilities:

• Coordinate and clarify customer requirements, including contract review, in collaboration with Sales departments
• Govern quality-relevant requirements with producers to determine feasibility
• Build initial sample reports, requirement lists, and certificate templates according to customer requirements
• Accurately measure physical dimensions, weights, and other critical parameters using appropriate tools, such as optical measuring devices, calipers, micrometers, and scales
• Conduct visual inspections for defects or deviations to ensure initial product samples meet quality standards and customer requirements
• Ensure complete and accurate initial sample reporting for successful customer submission and approval

✅ What We’re Looking For:

• Technician or comparable vocational training
• Proven experience in manufacturing, lab work, or quality control is preferred
• Familiarity with initial sampling processes, such as PPAP and PPF
• Knowledge of quality assurance techniques
• Experience in various material measurement methods, with a preference for elastomers and plastics
• Knowledge in the area of elastomers and PTFE/PU is preferred
• Strong computer skills, including MS Office, CAQ systems, and ERP systems
• Proficient in English (spoken and written)

Our benefits for You:

• Modern multicultural work environment that fosters diversity and inclusion
• Several weeks of induction training to familiarize you with our company, contacts, and structures
• An exciting, multifaceted, and interdisciplinary field of activity that keeps you engaged
• Extensive product training to ensure you are well-equipped to succeed
• Flexible office hours with remote work opportunities for a better work-life balance

Why join Us?

• Opportunity to drive real impact in a fast-paced manufacturing environment
• To be a part of a new and innovative team
• Career growth and professional development opportunities
• Be part of a company that values continuous improvement and sustainability
• Food vouchers to enjoy lunch or dinner on us
• Multisport card for fitness, swimming, and wellness activities
• Performance-related bonuses (additional variable payment)
• Comprehensive health insurance coverage

Ready to take the next step in your career? Send us your CV in English and become a key player in crafting our production excellence! You will be contacted by our HR team in Germany. 

Die TSS Stein am Rhein AG ist ein führender Entwickler, Hersteller und Lieferant von Flüssigsilikonteilen für anspruchsvolle Anwendungen in der Medizintechnik, pharmazeutischen Industrie, Automobilindustrie und der Nahrungsmittel- und Getränkeindustrie. Wir sind zertifiziert nach ISO 9001, IATF 16949, ISO 13485 und ISO 14001 und zählen rund 140 Mitarbeitende. Unter anderem stellen wir 2-K-Formteile sowie Teile für die Medizinbranche im Reinraum her. Zur Verstärkung unseres Teams im Qualitätswesen suchen wir am Standort Stein am Rhein zum nächstmöglichen Zeitpunkt einen

Qualitätsprüfer (m/w/d)

Deine Aufgaben – wir zählen auf Dich:

• Du überwachst die Produktqualität an den Dir zugewiesenen Spritzgiessmaschinen sowohl in der technischen Produktion als auch im Reinraum
• Du führst tägliche Sicht-, Mass- und Funktionsprüfungen gemäss Prüfplänen, Zeichnungen und geltenden Normen durch
• Du dokumentierst die Prüfergebnisse sorgfältig und erstellst aussagekräftige Prüfberichte
• Du unterstützt aktiv bei der Qualitätsvorausplanung (z. B. pFMEA, PQP) im Rahmen von Neuprojekten, Erstmusterprüfungen und Produktvalidierungen
• Du wirkst bei der Analyse von Fehlerursachen mit und begleitest die Umsetzung von Korrekturmassnahmen
• Du bearbeitest interne und externe Reklamationen eigenständig und lösungsorientiert
• Du führst Endprüfungen durch, erteilst Freigaben und erstellst die entsprechenden Abnahmeprüfzeugnisse

Dein Profil – das bringst Du mit:

• Du verfügst über ein gutes technisches Verständnis und kannst technische Zeichnungen sicher lesen
• Du arbeitest äusserst sorgfältig, genau und qualitätsbewusst
• Du übernimmst Verantwortung und überzeugst durch dein sicheres Auftreten sowie dein Durchsetzungsvermögen
• Du bringst fundierte Kenntnisse in gängigen Qualitätssicherungs-Tools mit (z. B. Statistik, 8D-Report, Fehleranalyse)
• Du hast mindestens 3 Jahre Berufserfahrung in der Qualitätssicherung oder in einer vergleichbaren Position
• Du beherrschst Deutsch in Wort und Schrift sicher; Englischkenntnisse sind von Vorteil

An uns schätzt man:

• interessante und abwechslungsreiche Aufgabenbereiche
• moderne Infrastruktur
• kompetentes Team
• dynamisches Unternehmen
• umfangreiche Einarbeitungszeit

Wenn wir Dein Interesse geweckt haben, freuen wir uns auf Deine Bewerbung unter Angabe Deiner frühestmöglichen Verfügbarkeit und Deiner Gehaltsvorstellungen.

Bei Fragen stehe ich Ihnen gerne zur Verfügung:

Jennifer Lawrenz-Mancino, HR, Tel: +41 52 742 01 73