Quality

Trelleborg Healthcare and Medical is seeking a NPD Quality Engineer to join their team. 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.

As a valued Trelleborg team member, you will enjoy:

• Greater opportunity for impact
• Competitive compensation
• Generous benefits package: Health, Dental, Vision, STD, LTD, Life, 401k
• Paid time off
•  Bonus

Qualifications:

Required:

• 4-year degree in quality, engineering, or any related field
• 2+ years in a manufacturing environment in a technical support role

Desired:

• ASQ Certified Quality Engineer

• Formal Six Sigma Yellow/ Green belt training
• Knowledge and experience with GMP/ISO Standards: ISO 9000/9001, ISO 13485, and FDA 21CFR 820/11 (4/210/211 as applicable)

Quality Engineer Expectations:
• 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

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
• 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, 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

Travel: Up to 25% across sites

Salary info: $78-92k

Apply here!

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 Quality Engineer to join the Delano, MN 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.

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.

Qualifications:

Required:

• 4-year degree in quality, engineering or any related field
• 7 + years in a regulated manufacturing environment 
• Knowledge and experience with GMP/ISO Standards: ISO 9000/9001, ISO 13485, and FDA 21CFR 820/11 (4/210/211 as applicable)
• Certified Six Sigma Yellow/Green
• ASQ Certified Quality Engineer and/or Auditor
• Class I, II, and/or III Medical device manufacturing experience

Desired

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

Responsibilities:

Quality Engineer Expectations:

• 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.

Salary range: Starting at $73k and up based on experience 

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 Quality Inspection Engineer at our Centre of excellence site in Rotherham, South Yorkshire, United Kingdom.

As the site Quality Inspection Engineer, you will be required to ensure that all finished goods meet the required quality standards and are ready for shipment meeting the production schedule. You will contribute to continuous improvements and will drive this to achieve top quality products which are supplied globally. In this role, you will play a crucial part in ensuring our production facility meets the quality standards set by Trelleborg Sealing Solutions Group Quality, upholding our high-quality standards within the production environment.

Reporting to the Quality Manager, the Quality Engineering Inspector will support the implementation, maintenance and ensure the applicability of the Integrated Management System in alignment with ISO9001:2015 and AS9100.

You will have 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

What be you’ll doing

• Reporting to the Quality Manager, the Quality Engineering Inspector will support the implementation, maintenance and ensure the applicability of the Integrated Management System in alignment with ISO9001:2015 and AS9100.
• Address product issues with validation, containment, and cross-functional communication while adapting to changing business needs, like increased inspections.
• Inspect incoming goods against drawings, standards, and ISO 9001 requirements.
• Operate measurement tools (e.g., verniers, gauges, micrometers, Pi tape, Calipers).
• Support the investigation of NCRs, corrective & Preventative Actions (CAPA) and Customer Complaints
• Assistance with third party audits and assessments, control principles such as calibration system, support FAIR and ISIR process, coordination and assist with internal and external concern and corrective action investigations and reports.
• Support and assist with site continuous improvement projects as identified by Quality Manager.
• To support handling of customer returns ensuring all returns working with the Quality manager to help identify relevant information in a timely manner
• Interact with other departs to support production activities as applicable.
• Develop and maintain company inspection reports
• Completed all QA, reports and documentation required by external bodies (Green passports, FAIRs, ISIR, Military body reports, photographic reports etc.)
• Work 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 query's or communicate information in relation to inspection and reporting.
• Create maintain and revise specialized quality documentation
• Assist with the process for dealing with and resolving non-conforming product
• Share 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

• Be technically competent within Engineering, preferably educated to degree level or equivalent in relevant Quality discipline.
• Have an academic qualification in Math’s and English (grade A or equivalent)
• Possess previous experience in a manufacturing/ Engineering environment.
• Have a minimum of 5 years’ experience in a quality engineering/ inspection role.
• Be skilled in measurement equipment, technical drawings, and Microsoft tools.
• Be highly skilled at reading engineering drawings
• Have knowledge of ISO 9001 and attention to detail in maintaining quality data.
• Possess previous experience of recognized Quality Systems (AS9100/ISO9000/).
• Be able to apply sound analytical techniques and have good verbal and written communication skills.
• Have experience of the requirements for our business (e.g. Aerospace, Automotive etc.).

Experience of producing and collating FAIRS and associated documents would be beneficial but not essential as training will be given.

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

• Has a progressive ‘can-do’ attitude, willingness to learn, a keenness towards problem solving and commitment to continuous improvement are essential to the role.
• Capable of making independent decisions, whilst being appreciative of other departments' considerations.
• Excellent computer skills including Word & Excel
• Knowledge of Health & Safety requirements
• Flexible and Trustworthy
• Possess a commercial approach and an attention to detail.
• Hardworking, reliable
• Has 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, with the ability to multi-task and work to tight deadlines, excellent time management.
• Knowledge of manufacturing processes.
• Strong analytical and problem-solving skills.
• Be able to exercise good judgment and make timely decisions.
• Continuous improvement mindset.
• Demonstrates a high wok ethic.
• Can work under pressure in a fast-paced environment.
• Works quickly but methodically.
• Possess effective written and oral communication skills

We offer great benefits in return:

• An attractive and competitive salary
• 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 wellbeing app, physio and counselling support
• Free parking
• Discounted Costco Wholesale membership
• Free fruit & hot drink vending
• Mental Health First Aiders to support your wellbeing

 Hours of work

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

Do you have the right to work in the UK?

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! 

Influencez le futur. Accélérez votre carrière avec Trelleborg et commencez à façonner l’Industrie depuis l’intérieur.

Qui sommes-nous ?

Trelleborg Industrial Solutions (TIS) est un leader mondial de solutions polymères innovantes pour l’industrie. TIS est l’une des trois Business Areas du Groupe Trelleborg, avec un total d’environ 6 000 employés dans le monde.

Fluid Handling Solutions (FHS) est une Business Unit de Trelleborg Industrial Solutions. Avec plus de 1.300 employés, Trelleborg FHS est un acteur clé offrant des solutions de haute performance : systèmes de sécurité pour le transfert de pétrole, tuyaux industriels, feuilles de caoutchouc, joints d’expansion et solutions anti-abrasives pour le secteur minier. Basée à Lyon - France, Trelleborg FHS dispose de sites de production en France, Turquie, Espagne, Royaume-Uni, Pays-Bas, République Tchèque et Australie.

1. Rôle

L’ingénieur qualité et sécurité est responsable de garantir que les produits, processus et services respectent les normes de qualité, les réglementations en vigueur et les attentes des clients tout en assurant la sécurité des employés, des équipements et des installations. Il joue un rôle stratégique en pilotant des initiatives d’amélioration continue, en veillant à la conformité réglementaire et en promouvant une culture d'excellence et de prévention au sein de l’entreprise.

2. Tâches et Responsabilités

Conformité & Sécurité :

• Identifier, évaluer et contrôler les risques professionnels et environnementaux.
• Etablir des consignes et procédures de sécurité et définir le système de surveillance approprié, garantir la mise à jour du DUERP
• Garantir la mise en œuvre de la VGP
• Elaborer les plans de sensibilisation et de formation à la sécurité, l’hygiène et les conditions de travail, sensibiliser les nouveaux embauchés à la sécurité
• Assurer la conformité avec les réglementations locales, nationales et internationales en matière de sécurité
• Organiser des audits, des formations et des sensibilisations pour réduire les accidents et améliorer la culture sécurité
• Gérer les incidents et accidents : analyse des causes, mise en œuvre des actions correctives et suivi
• Développer et assurer la communication Sécurité

Opérationnel :

• Collaborer avec les équipes de production pour garantir le respect des standards qualité et sécurité au quotidien.
• Assurer la mise en œuvre et le suivi des plans d’action d’amélioration.
• Contrôler et analyser les processus opérationnels pour détecter et corriger les non-conformités.
• Garantir le traitement des réclamations techniques clients et assurer la coordination avec le processus achat pour le traitement des réclamations fournisseurs.

Stratégie :

• Définir et piloter la stratégie qualité et sécurité en alignement avec les objectifs de l’entreprise
• Mettre en place des indicateurs de performance (KPIs) pour mesurer les progrès en qualité et sécurité.
• Proposer des initiatives innovantes pour améliorer les systèmes qualité et sécurité.
• Animer et piloter la revue de direction qualité – ISO 9001

Team Leadership:

• Former, sensibiliser et accompagner les collaborateurs sur les bonnes pratiques qualité et sécurité.
• Fédérer les équipes autour des objectifs d’amélioration continue.
• Être le référent interne pour toutes les questions liées à la qualité et à la sécurité.

Assurance Qualité :

• Superviser les audits internes et externes (ISO 9001, clients, réglementaires).
• Élaborer et maintenir les manuels qualité et sécurité.
• Garantir le respect du calendrier des vérifications périodiques des instruments de mesure et des qualifications du personnel (soudeurs)
• Gérer les réclamations clients et mettre en place des actions correctives adaptées.
• Etablir le plan de surveillance des produits selon les normes applicables (Service Inspection Interne ?)
• Assurer la veille réglementaire et normative.

Rapport et communication :

• Rédiger des rapports sur les performances qualité et sécurité, incluant les résultats des audits et des analyses de risques.
• Communiquer avec les parties prenantes (internes et externes) sur les plans d’action et les progrès réalisés.

Engagement:

• Promouvoir une culture d’amélioration continue et de prévention des risques.
• Impliquer tous les départements dans l’atteinte des objectifs qualité et sécurité.
• Suivre et analyser les retours d’expérience pour garantir une amélioration constante.

3. Education et Expérience

Education:

• Formation : Ingénieur ou Bac+5 / diplôme Bac +3 avec expérience en qualité, sécurité, environnement ou domaine connexe.
•  Expérience : Minimum 3-5 ans dans un poste similaire, idéalement en environnement industriel.
• Langues : Maîtrise du français et de l’anglais.
• Autonomie, rigueur et esprit d’analyse.

4. Compétences

Compétences techniques

• Maîtrise des normes ISO (9001 ...) et des réglementations HSE.
• Connaissance des outils qualité (AMDEC, 8D, 5S, etc.) et des méthodologies de résolution de problèmes.
• Capacité à effectuer des audits et analyses de risques.

Compétences stratégiques

• Analyse et interprétation des données pour la prise de décisions.
• Vision stratégique pour aligner les initiatives qualité et sécurité avec les objectifs globaux de l’entreprise.

5. Interfaces et parties prenantes clés

Interaction avec :

• L’équipe opérationnel incluant production, technique, qualité, logistique…
• Le service client ainsi que les ventes
• Coordinateur QSE group
• Les organismes certificateurs
• Auditeurs

6. Géographie à couvrir et exigences de déplacement

Poste local donc un minimum de déplacements est requis pour les réunions PA/BU (quelques jours/an).

Basé sur site à Lyon Dardilly, France.

7. Caractéristiques comportementales

• Excellentes compétences en communication et en pédagogie pour sensibiliser et mobiliser les équipes.
• Leadership naturel pour accompagner le changement et promouvoir une culture d'excellence en qualité et Sécurité
• Capacité à travailler en équipe dans un environnement transversal.

Comment candidater ?

Trelleborg est un employeur promouvant l’égalité des chances. Nous célébrons la diversité et nous nous engageons à créer un environnement inclusif pour tous les employés. Nous veillerons à ce que les personnes handicapées bénéficient des mesures d’adaptation nécessaires leur permettant de candidater. Veuillez nous contacter pour toute demande particulière.

Passez à l’action !

Êtes-vous celle ou celui que nous recherchons ? Déposer votre candidature pour un examen immédiat

At Trelleborg our people are #shapingindustryfromtheinside 

Imagine leveraging your strong Quality experience for one of the leading contract manufacturers in the world. Seize this rare opportunity to be part of an exciting 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 Quality Director to join their team. The position is responsible for the Leadership and management of personnel and resources to ensure adherence and compliance to Trelleborg Medical Solutions Quality Management System (QMS) processes and policies.

Qualifications:

Required:

• 4-year degree in manufacturing or industrial engineering, quality assurance, regulatory affairs, science, or related field
• 10 years’ experience in quality assurance and/or regulatory affairs
• 5+ years Leadership/Supervisory-level experience, with decision-making authority/responsibility
• Knowledge and experience with GMP/ISO Standards: ISO 9000/9001, ISO 13485, FDA 21CFR 820/11 (4/210/211) and other Regulatory as applicable
• Class I, II, and/or III (or equivalent) medical device manufacturing experience
• Auditor certificate or equivalent experience with both internal and external regulatory agencies

Desired:

• Master’s degree in science, engineering, or equivalent
• ASQ Certification for CQA, CQM, Lean Six Sigma Black Belt Certification
• 5 years in Medical Device or Medical Device Supplier environment

Responsibilities:

• Drive, conduct periodic reviews, and support QMS initiatives as well as implement and report on continuous improvement activities.
• Ensure the promotion and awareness of regulatory and customer requirements throughout the organization.
• Establish and monitor Quality Department goals and objectives.
• Ensure and manage the processes and functions needed for employees to execute, implement, and maintain Quality Systems and its standards, specific to:
• Corrective Action/Preventative Action System
• Quality Manual
• ISO Certifications
• Equipment/Software/Environmental Control System
• Non-conformance System
• Document and Record Control System
• Supplier Quality and Materials Control System
• Management Control System

Customer Feedback/Control System

ITAR (Empowered Official Responsibility)

• Quality Systems supporting Production and Process Controls
• Provide resources for new product reviews and customer correspondence pertaining to projects or complaints.
• Provide resources for review, control and maintenance for all Quality System required documentation.
• Manage, develop, mentor, coach, and review Quality department employees.
• Manage annual internal audits on all relevant Quality Systems and serve as Quality representative for Customer and Regulatory audits.
• Serve as the Quality Management representative for the organization.
• Ensure establishment and maintenance of site regulatory registrations.
• Lead and/or support QS integrations for existing and future organizational acquisitions.
• Support for integration of new manufacturing capabilities, product transfers, development programs, and customers.
• Promote and support a Quality Culture throughout the organization.
• Other duties as assigned

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
• Demonstrates senior leadership abilities with capability to accept responsibility and delegate authority
• Professional demeanor working with others
• Good math skills
• Good technical writing skills
• Working computer knowledge of Word, Excel
• Comprehensive working knowledge of applicable corporate policies, Work Instructions, and other procedures
• Ability to give directions, make decisions, give constructive criticism
• Competent knowledge of quality control evaluation devices including comparators, microscopes, pull tester, scales, and gauges
• Ability to interpret engineering drawings, specifications and other customer documents to support required inspections
• Ability to maintain a professional and respectful relationship with coworkers and company
  • Desire to delight both internal and external customers by offering encouragement, fostering teamwork and addressing conflict appropriately
• Statistical analysis, technical writing, non-contact measurement device

Geography to cover and travel requirements.

Up to 25% travel, as required

Für unsere Qualitätsabteilung am Standort in Gärtringen suchen wir Dich, zunächst befristet auf 2 Jahre, für die Sachbearbeitung der Qualitätssicherung (m/w/d). Werde Teil eines internationalen Teams im Supply Chain Management Bereich, mit Schwerpunkt im Qualitätsmanagement und in der logistischen Reklamationsbearbeitung.

Du übernimmst eigenverantwortlich:

• Durchführung von Bestandskontrollen und -korrekturen in Bezug auf Falschlieferungen oder Fehlmengen aus Kundenreklamationen
• Prüfung und Bewertung von Artikeln und Labels an den Kundenretouren
• Sicherstellung der Chargenintegrität und Definition von Verschrottungsmaßnahmen bzgl. der Schlechtware
• Erfassung von Kundenreklamationen und Erstellung von 8D Berichten
• Abteilungsübergreifende Nachverfolgung der Abstellmaßnahmen, in enger Abstimmung mit dem Einkauf, dem Vertrieb und dem Logistik Center
• Reklamationsachbearbeitung und Pflege des Lagerhaltungssystems (SAP EWM) und des Qualitätsmanagementsystems (CAQ)
• Systemverwaltung der Produktquarantäne und Zuweisung von Produktqualitätscodes  
• Realisierung von Cross Checks betreffend der Warenausgänge, Artikelmengen, Kundenspezifikationen und gemäß der vorgegebenen Qualitätsstandards
• Bearbeiten von spezifischen Produktzertifikaten für Kundenlieferungen

Dafür bringst Du mit: 

• Erfolgreich abgeschlossene kaufmännische oder technische Berufsausbildung, mit Fachrichtung Supply Chain Management oder ähnliches
• Berufserfahrung im Bereich der Qualität, idealerweise im Reklamationsmanagement wünschenswert
• Ausgeprägte Zuverlässigkeit und Genauigkeit, strukturierte und eigenständige Arbeitsweise
• Organisationstalent, Teamorientierung, Belastbarkeit und zielorientiertes Arbeiten
• Sehr gute Deutsch- und Englischkenntnisse (in Wort und Schrift)
• SAP Kenntnisse von Vorteil, sicherer Umgang mit EDV-Systemen und MS-Office

Wir bieten Dir: 

• Eine intensive und umfangreiche Einarbeitung in der Qualitätssicherung und in den logistischen Prozessabläufen
• Moderne Arbeitsumgebung im neuen Logistik Center in Gärtringen (Neubau 2024)
• Vielfältiges und gesundes, kulinarisches Angebot in unserem Betriebsrestaurant
• Gleitzeit und flexible Arbeitszeitmodelle, sowie Vereinbarkeit von Beruf und Familie
• Gute Verkehrsanbindung (S-Bahn/Bus/Autobahn) 

Nimm Deine Karriere jetzt in die Hand! Wir freuen uns auf Deine Bewerbung.

Bei Fragen steht Dir das Recruiting Team sehr gerne zur Verfügung:

Carlos Lopez, HR
Tel: +49 711 7864-364

Stefani Sabotinova, HR
Tel: +49 711-7864-749

#ShapingIndustryfromtheInside

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

Summary

The primary role is the inspection of components to ensure compliance with specifications.

Tasks and Responsibilities

• Conducts inspections to ensure compliance with product specifications. Inspections include visual, dimensional, functional, and physical testing on product from all departments.
• Performs all duties per appropriate work instructions.
• Completes required documentation.
• Verifies packaging and documents for shipping parts.
• Performs accurate data entry.
• Collaborates and gathers documentation or data, tests product or materials for root cause analysis, investigations, and drives continuous improvement activities.
• Communicates orally in a professional, courteous manner. Written communications should be clear and concise.
• Serves as a good team player.
• Uses Lean Enterprise methods to reduce waste and complexity in all processes and organizes work area.
• Ensures the work area is clean and safe.
• Assists with filing or scanning for QA Dept.
• Able to accurately scan processing records to computer files for archiving.

Education and Experience

Required

• High School Diploma, or equivalent
• 0-3 Years experience in a manufacturing environment. 

Desired

• Experience with clean room manufacturing
• Experience with good manufacturing practices in a regulated industry

Competencies

• 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 Intermediate skills using Microsoft Office and set up meeting in Outlook
• Comprehensive understanding of applicable Work Instructions and Standard Operating Procedures
• Comprehensive understanding of quality control and production documentation
• Proven competency with applicable inspection equipment including, but not limited to, comparators, microscopes, calipers, tensile tester, scales and gauges
• Working knowledge of prints and customer supplied drawings and documentation
• Good manual dexterity
• Correctable normal reading distance vision
• Good organizational skills with the ability to pay strict attention to details
• Ability to work with minimal supervision, follow directions and make sound decisions
• Strong team skills
• Understanding of acceptance sampling
• Ability to maintain a professional and respectful relationship with coworkers and company
• ability to read, write, speak and understand the English Language 

Application

Last Application Date: 02/28/2025

Apply Here

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Job Beschreibung

Du bist verantwortlich für die Sicherstellung der Qualitätsprozesse während der Projekt- und Ramp-Up Phase. Du erstellst die Qualitätsvorausplanung für Projekte unter Berücksichtigung der internen Produktionsumfänge und der Supplier- und Customer Quality Belange. Du planst die termingerechten Qualitätsaktivitäten jeweiliger Projekte mit dem Ziel die Erreichung der Projektziele und Kundenzufriedenheit. Du stellst sicher, dass die Qualitätsaktivitäten entlang des Produktentstehungsprozesses (PEP) zu den jeweiligen Q-Gates durchgeführt und leitest bei Abweichungen Korrekturmassnahmen ein, überwachst deren Umsetzung und weist die Effektivität dieser nach. Du arbeitest zusammen mit den Teams und unterstützt bei Prozessqualifizierungen, Validierung von Testmethoden, Prozessentwicklung/-Validierung (IQ/OQ/PQ) und anderer Qualitätsprozesse unter der Einhaltung des Qualitätssystems des Unternehmens  IATF 16949 und ISO 13485 und der geltenden externen Anforderungen und Normen, einschliesslich die Gewährleistung geltender Kundenvorschriften. Du entwickelst kreative Ansätze und Lösungen für Probleme zu Unterstützung der internen und externen Kunden.

Folgende Kenntnisse und Kompetenzen sind auszuweisen

• Methoden zu Qualitätsvorausplanung und Prüfplanung
• Beurteilung und Optimierung der Qualitätssituation
• Verbesserungszyklen begleiten, moderieren, visualisieren und kommunizieren
• Statistische Methoden Testverfahren
• Qualitätsmethoden im Produktentstehungsprozess
• Methoden zur technischen Risikoanalyse
• Statistische Versuchsplanung (Prozesscharakterisierung, Versuchsplanungsergebnissen)
• Erstellung und Ausführung von Qualitätsplänen für Qualitätsmanagementsysteme und Projekte zur Erreichung organisatorischer Ziele
• Unterstützung des Personals in den Bereichen Konstruktion, Fertigung und Inspektion bei der Entwicklung, der Methoden, Werkzeugausstattung, Validierung und anderen Bereichen die mit der Kontrolle des Produkts zusammenhängen
• Überprüfung und Sicherstellung der Übereinstimmung aller Validierungsdokumente und Aufzeichnungen mit dem QMS
• Regelmässiges prüfen von Arbeits- und Prüfanweisungen und Unterstützung der Qualitätssicherung und Qualitätstechnik
• Initiierung und Durchführung von Ursachenanalysen unter Verwendung von statistischen Fähigkeitsanalysen zur Lösung von Problemen
• Unterstützung anderer Qualitätsaktivitäten wie Kundenbeschwerden (CC) und gemäss Verfahren, 8D Methodik, Korrektur- und Vorbeugungsmassnahmen (CAPA), soweit erforderlich
• Unterstützung bei internem und externem Audit
• Prüfung der Kundenanfragen auf Machbarkeit der qualitätsrelevanten Belange wie geltende Standards und Normen 

Dein Profil

• Abgeschlossene Höhere Fachausrichtung im Bereich Qualitätsingenieurwesen oder vergleichbare Qualifikation
• 3+ Jahre Erfahrung im Qualitätsmanagement und in einer regulierten Produktionsumgebung mit technischen Unterstützungsfunktion
• Verhandlungssicheres Deutsch und Englisch
• Fähigkeit, klar zu kommunizieren und Ideen, Informationen und Anweisungen effektiv zu vermitteln und entgegenzunehmen
• Bereitschaft sich um hervorragende Leistungen zu bemühen und fehlerfrei Arbeit zu leisten
• den Wusch sowohl Kunden als auch Mitarbeiter zu begeistern indem sie Ermutigung bieten, Teamarbeit fördern und Konflikte angemessen angehen
• Engagement für unternehmensweite Verbesserungen

Unsere Werte & Benefit

• Freiraum & Eigenverantwortung 
• Internationalität & Abwechslung jeden Tag
• Privates & berufliches Leben in Balance
• Miteinander auf Augenhöhe
• Kulturelle Vielfalt
• Moderne und klimatisierte Arbeitsumgebung
• Kostenlose Parkplätze 

Wenn wir Dein Interesse geweckt haben,

freuen wir uns auf Deine Bewerbung unter Angabe Deiner frühestmöglichen Verfügbarkeit und Deiner Gehaltsvorstellungen.

Bei Fragen stehe ich Dir gerne zur Verfügung:

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

Make your mark on the future!

Accelerate your career with Trelleborg and start shaping industry from the inside.

Who are we?

Trelleborg Industrial Solutions is a leading global supplier of innovative polymer-based solutions. We are one of three business units within the Trelleborg Group with a total of approximately 6,000 employees around the world. 

About the Job

 As a Production Quality Engineer, you will be responsible for assessing the production processes by ensuring quality and reliability are adhered. You will monitor initial sampling, recording and processing quality enquiries, complaints and operational quality management in production.  

This is a permanent role based in our Velten office.

Tasks and Responsibilities

• Ensure and assess production processes in terms of quality and reliability  
• Be the first point of contact for production and outgoing goods for quality issues  
• Monitor product quality, e.g. tracking corrective and improvement measures in accordance with quality management specifications 
• Preparation of initial sample inspection reports (FAI) and FAI defense reports for customers, including FAI on-site inspections   
• Development of concepts for quality planning in production, e.g. creation of quality control plans  
• Participation in subscription change requests  
• Initiation and coordination of the 8D process  
• Management of special approvals, including tracking of corrective and improvement measures 
• Management and optimisation of quality measurement systems, in particular evaluation of measurement data and improvement of metrological procedures for recording component dimensions, as well as MSA implementation 
• Support with customer audits, issuing certificates and processing customer complaints for two locations in Germany and Switzerland, including monitoring remedial measures Management of quality projects 

Your profile

• Completed technical studies (university/university of applied sciences), e.g. mechanical engineering or a comparable qualification  
• Several years of relevant professional experience in production-related quality management  
• Basic practical knowledge in the application of quality management methods, e.g. process FMEA, 8D reports, CIP and PPAP  
• Experience with the 3D machine for creating programmes and carrying out measurements is desirable 
• Business fluent in German and English 
• Experience with ISO 9001, ISO/TS 22163 or IATF 16949 standards an advantage 
• High level of organisational and methodological skills, problem-solving ability and assertiveness  

Our offer and benefits

• A responsible position in an internationally active production company 
• Familiar and collegial working atmosphere  
• Attractive remuneration according to the collective agreement for the rubber industry East with 13th monthly salary and holiday pay 
• Up to 35 days holiday 
• Flexitime and hybrid working 
• Company pension scheme 
• Individual training opportunities 
• Canteen subsidy 
• Company events, such as Christmas parties or summer parties 
• Commitment and support for social projects  

Sound like the role for you?

Submit your CV in an English format and any relevant supporting documentation to shape your career.

Take the opportunity to be part of a transformative organization that enables customers to engineer a better world!

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

Do you want to experience new challenges and innovate the future of engineered polymer solutions? Accelerate your career with Trelleborg and start shaping industry from the inside.

Who are we?

Trelleborg Industrial Solutions (TIS) is a global leader in innovative polymer-based solutions for key industries and critical infrastructure. We are one of two Business Areas within the Trelleborg Group, with a total of about 6 200 employees around the world. 

About Trelleborg Marine & Infrastructure business unit - with our comprehensive portfolio of smart engineered solutions designed for berthing, docking, and mooring, navigation and piloting, built and offshore infrastructure, we work to meet some of the core challenges centered around safety, efficiency, and sustainability. Join us and be part of a world-class team that is dedicated to excellence and innovation.

About the Job

I. General information:

1. Job Title: Quality Manager
2. Report to: Vietnam General Manager
3. Subordinates: Quality Engineer
4. Working Location: Phu My 3 Specialized Industrial Park, Ba Ria & Vung Tau Province, Vietnam (Shuttle bus will be provided from 3 locations: Ho Chi Minh City, Bien Hoa City, and Vung Tau City)

II. Summary of the role:

• Establish, maintain, and improve company Quality management systems to ensure that all quality functions in the areas to meet internal and external quality expectations
• Develop and implement a systematic procedure to evaluate supplier quality management systems, identifying gaps and establishing corrective actions
• Responsible for plant quality assurance effort with emphasis on identification and solution of process, material or labor problems that could compromise plant commitments on quality.
• Responsible for testing & inspections, to ensure incoming, process, and finished products meet requirements of customers and company.
• Preparation of all external quality reports for customers to meet contract and project requirement.
• Responsible for internal quality report to identify problems, promote project management in areas involving quality, and resolve problems. Using QA/QC tools and methodologies for the analysis of quality issues and come up with improvement plan or proposal.

III. Tasks & Responsibilities:

• Formulated the company's quality objectives, monitored the completion of the objectives, reported to the general manager and management meeting in a timely manner, and took corresponding measures to ensure the realization of the objectives;
• Monitored the company's internal production performance and promoted quality improvement to reduce scrap rate and waste cost;
• Monitor customer feedback and complaints to ensure 100% customer response rate within a limited period. At the same time, conduct thorough analysis and countermeasures for each feedback, and standardize countermeasures to avoid recurrence;
• Monitor the material quality of suppliers and assist suppliers to improve the quality to meet the material quality requirements;
• Monitor the change point management of the company, including design change, process change, material change, supplier change, etc., to ensure the stability of product quality after the change;
• Responsible for customer factory audit, pass customer audit and show the highlights of the company;
• Responsible for the staff management, guidance and training of the quality members, so that they have the ability to work on the job, and gradually become capable and willing excellent staff;
• Working together with Sales, Production, and other team for new product / new application development
• Working together with Production, Technical, and Supply chain for project review and FAT protocol
• Deal with customers and related parties on quality requirements and complaints
• Contribute to the creation and implementation of strategy, policies, processes, and procedures & best practice Lean vision to aid and improve operational performance
• Making headcount plan according to business forecast, recruiting & training of operators to meet the need of production (combined effort with HR), measuring operators’ performance and maintaining an effective salary & compensation system; Confers with management and colleagues to solve workers problems, complains and grievance
• Close cooperation with other departments, particularly Production, Supply chain, Technical, Purchasing, and Sales departments

About the Ideal Candidate

• Engineering bachelor’s degree or above.
• Minimum 5 years experience as manager.
• Minimum 3 years MNC working experience.
• Familiar with ISO9001, ISO14001 and ISO45001 management systems.
• Lean six sigma qualification is preferred.
• High communication and executie skill.
• Good working attitude and teamwork spirit.
• Good computer skill, especially in Microsoft office.
• Fluent English in oral communication and writing. 

What we offer?

• Generous Paid Time Off: Enjoy 16 days of annual leave to relax, recharge, and pursue your passions outside of work.
• Comprehensive Health Coverage: Stay healthy and worry-free with Private Health Insurance from PTI, covering not only you but also all of your loved ones! (Husband/Wife/Childrens)
• Security from Day One: We fully cover your Social Insurance contributions, even during your probation period, ensuring peace of mind right from the start.
• Competitive Rewards: Benefit from a 13th-month salary and a performance-based KPI bonus of up to 2 months.
• Convenient Commute Options: Forget the hassle of commuting! We provide a comfortable Shuttle Bus service from Ho Chi Minh, Bien Hoa, and Vung Tau straight to our factory.
• Additional Perks & Allowances: Enjoy added support with allowances for lunch, phone, and petrol, making your work-life smoother and more comfortable.
• Accelerated Learning and Growth: As a newly established company, we have a lot of exciting projects ahead! This means you'll have numerous opportunities to learn, grow, and make a real impact right from the start.
•  

Application Process

The application deadline for this role is 17/02/2025. After this date, our team will review all applications, and shortlisted candidates will be contacted within 3 working days. If selected, you can expect to hear from us by 20/02/2025. We appreciate your patience and interest!

Trelleborg is an equal opportunity employer! We celebrate diversity and are committed to creating an inclusive environment for all employees. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Call to Action

“Don’t delay! We’re hiring as quickly as possible”

At Trelleborg our people are #shapingindustryfromtheinside 

Trelleborg is a world leader in engineered polymer solutions for almost every industry on the planet. And we are where we are because our talents brought us here. By specializing in the polymer engineering that makes innovation and application possible, Trelleborg works closely with leading industry brands to accelerate their performance, drive their business forward—and along the way, shape the industry and progress that will benefit humankind in the exciting years ahead. Our people are Shaping Industry from the Inside. Why don´t you join us? 

Located in Pawling, NY, Pawling Engineered Products is proud to be a part of Trelleborg since October, 2022.

Job Description

Quality Inspector

You will utilize your knowledge and natural mechanical aptitude to provide in-process/final inspection to ensure the product meets customer requirements for dimensional and cosmetic characteristics. We will rely on you to perform the following:

• Conduct incoming and in-process inspection of products as specified.
• Evaluate first article samples as assigned.
• Communicate any deviation intolerances, specifications, etc. to the Quality Supervisor. Follow up with accurate written non-conforming material reports as required.
• Research customer complaints as requested and evaluate returned goods. Recommend corrective action for approval.
• Conduct 100% final inspection on products for shipment.
• Maintain inspection tools.
• Calibrate measurement equipment as assigned.
• Support the ISO process by being a team player and demonstrating clear, consistent, honest communication.

Basic Qualifications:

• Read, write and speak English so as to understand customer requirements and to prepare reports and documentation.
• Good verbal and written communication skills
• Strong math skills to include decimals, fractions, and conversions
• Ability to use measurement and inspection tools including, but not limited to calipers and rulers
• Ability to read and understand prints.
• Basic computer skills
• Good organizational skills

Physical Requirements for a Quality Inspector:

This position requires the ability to lift and carry up to 25 lbs. frequently during the workday. Most of the day is spent in a standing position with frequent bending and/or squatting.

Benefits:

• Medical, dental, 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)
  • This is a first-shift position with a starting rate commensurate with experience, the minimum starting wage is $19.00 per hour

APPLY HERE

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