Trelleborg is looking to add a Quality Engineer to our team!

The Aerospace Quality Engineer supports AS9100-compliant quality activities for complex aerospace components and assemblies across commercial, defense, and space programs. This role ensures product conformity by translating customer, regulatory, and contractual requirements into effective inspection plans, manufacturing controls, supplier flow-downs, quality records, and audit-ready evidence. The Quality Engineer applies risk-based thinking, structured RCA/CAPA, AS9102 FAI/FAIR practices, MRB support, supplier quality follow-up, and data-driven improvement to prevent defects, reduce variation, protect product safety, and drive timely closure of customer, supplier, and production quality issues.

Tasks and Responsibilities:

• Ensure AS9100 QMS compliance by translating customer, regulatory, and aerospace requirements into inspection plans, manufacturing controls, supplier flow-downs, and quality records.
• Protect product safety and conformity by identifying quality risks, supporting production readiness, verifying special process controls, and ensuring requirements are met before delivery.
• Lead nonconformance, escape, complaint, and supplier-defect investigations; drive containment, root cause, corrective action, and preventive action through effective closure.
• Prepare, review, and submit AS9102 First Article Inspection Reports (FAIR/FAI) and supporting evidence to verify product and process conformance.
• Participate in MRB activities, disposition nonconforming material, and ensure risk-based containment, recovery, and customer/regulatory compliance.
• Perform and support internal, supplier, customer, and third-party audits; maintain audit readiness and objective evidence for AS9100 requirements.
• Evaluate and improve supplier quality performance through audits, scorecards, corrective action follow-up, and support for defect and delivery-risk reduction.
• Partner with engineering, manufacturing, inspection, program management, supply chain, customers, and suppliers to resolve quality issues and improve manufacturability, repeatability, and compliance.
• Maintain accurate quality documentation, certifications, inspection records, customer portal submissions, and status reporting for open quality actions.
• Use quality data, trend analysis, and continuous improvement methods to reduce variation, prevent recurrence, and improve process performance.

Education and Experience: 

• Bachelor's degree in a technical discipline required.
• 3+ years in quality engineering, manufacturing engineering, or process engineering in a regulated manufacturing environment.
• 2+ years hands-on with nonconformance management, root cause analysis, CAPA, MRB activities, and resolution of customer and supplier quality issues.
• Proficient in GD&T and reading engineering drawings, specifications, inspection plans, customer flow-down requirements, and manufacturing process documentation.
• Working knowledge of AS9100 and AS9102; FAIR preparation experience preferred
• Familiarity with PPAP, APQP, PFMEA, SPC, Lean/Six Sigma preferred

• Proficient in Microsoft Office Suite (Excel, Word, PowerPoint, Visio), experience with Minitab, ERP/MRP systems, customer portals, and electronic QMS platforms highly desirable.

• ISO 9001 / AS9100 internal/lead auditor experience a plus

Competencies: 

• AS9100/AS9102 quality mindset with sound judgment in regulated manufacturing environments.
• Product conformity focus, including drawings, GD&T, inspection plans, FAI/FAIR, certifications, and customer flow-downs.
• Risk-based nonconformance management, containment, MRB support, and customer-impact escalation.
• Disciplined RCA/CAPA execution using structured problem-solving methods (5-Why and 8D).
• Strong documentation discipline for traceability, audit evidence, quality records, and customer portal submissions.
• Data-driven improvement using Excel, Minitab, SPC, process capability, Pareto analysis, trends, and basic statistics.
• Effective collaboration with manufacturing, inspection, engineering, suppliers, customers, and cross-functional teams.
• Self-directed ownership, clear communication, and ability to manage production priorities to closure.

Travel: 

• The Quality Engineer may be required to travel throughout North America, Europe, and Asia.

The final compensation offered to the candidate may be based on geographical location, work experience and/or skill level. Additions to the compensation packing, including but not limited to paid time off, insurance benefits and 401(k) eligibility, will be outlined at the time of the job offer.

Application: 

Compensation range: $75,000-$105,000

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
Vision insurance

Apply here!

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.

Trelleborg is looking to add a Quality Inspector to our team!

The Quality Inspector plays a critical role in ensuring that all incoming and outgoing materials meet established customer specifications, company standards, and regulatory requirements. This position is responsible for conducting thorough inspections, verifying product quality, and maintaining accurate documentation to support compliance and operational excellence. The ideal candidate is detail-oriented, reliable, and capable of working both independently and collaboratively in a fast-paced environment.

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 offsite training when required, 5%

Compensation range: $24.00-28.00/hour

Benefits:

• 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
• Vision insurance

Apply here!

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. 

Trelleborg Medical Solutions is seeking a VP Global Quality and Regulatory, based from their Minneapolis MN headquarters. 

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

• Competitive compensation: $220,0000-225,000 + 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 have the autonomy and support to lead the production team and impact the production of life-saving devices.
• Growth and advancement: Join a global company that loves to promote from within and allows for advancement into one of their many other U.S. locations!

This position is a strategic business partner to the BA President in managing Global Regulatory and Quality functions throughout the BA.

This position drives the strategy for the BA to comply with the requirements of the global landscape for class I, II & III productions, in a cost effective and pragmatic manner.   The position takes a holistic approach to include manufacturing, services and 3rd party purchase for resale products into scope, and other business models as the business develops.   Stressing global in approach, inclusive of sales and logistic centers.

Tasks and Responsibilities

• Aligns the quality strategy to fulfill the business area strategy.
• Owns global Quality and Regulatory budget and cost-of-quality performance
• Drive quality as a competitive advantage enabling growth and commercial success
• Defines and tracks KPI’s aligned to business outcomes
• Champion of global culture of quality, accountability and continuous improvement
• Deploys Lean/Six Sigma or equivalent methodologies across the organization
• Lead implementation and optimization of eQMS and digital regulatory tools
• Utilizes data analytics and predictive insights to proactively manage quality risks
• Owns strategy with corporate objectives and manage product registrations in existing and emerging markets. Inclusive of material regulatory.
• Represents the company with regulators, industry bodies and external stakeholders

Oversees the remainder with delegation to their team.

• Oversee FDA listings, EU conformity declarations, etc., to ensure clearance to distribute products.
• Oversee product listings, declarations and regulatory approvals (ie 510(k), ISO, CE, CMDCAS) are submitted in accordance with all applicable regulations and are kept up to date. Responsibilities include: determining the type of listing, registration, and/or approval needed (by country); classifying the device appropriately per 21CFR, CE, CMDR, etc.; preparing & filing listings, 510(k)’s, Declarations of Conformity, etc. to all applicable countries.
• Oversee the Vigilance/Medical Device Reporting System including preparing and submitting reports and maintaining records/files of incidents including any remedial actions taken. Coordinate Recall & Field Action situations to comply with US & international regulations and company policies/procedures.
• Responsible for assuring products, labeling/packaging and advertising are in compliance with all applicable regulations.
• Coordinate FDA/EU or any other country required inspections and audits, respond to findings and maintain records of all activities. Assure that any product detentions are promptly resolved; provide interface with FDA field offices as needed.

Education and Experience

• 15 years plus of experience in a global organization within a regulatory or quality function
• Minimum of 4 Year College degree in a technical field
• Masters is plus
• Ability to work in a fast paced, global environment with matrix organization

Competencies

• American Society for Quality (ASQ) certification and/or Regulatory Affairs Certification (RAC) preferred
• Core competency as demonstrated by previous compliance responsibility for ISO 13485 and 14971; MDD; MDR; FDA cGMPs; FDA QSRs; UL; CE; and IEC Standards
• Subject Expert in US FDA Regulations, Standards, Documentation, Labeling
• Knowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process
• Knowledge of 21 CFR 801, 803, 806, 807, 820
• Knowledge of FDA guidelines and ISO standards for Medical Devices
• Knowledge in IEC 60601-1 and foreign regulations for medical devices
• Working knowledge of Medical Device Regulations, Quality Systems Regulations, and other US and Intl regulations and standards that apply to the Class II and Class I medical device industry
• Working knowledge of and ability to assist in the creation/review of technical sections in support of regulatory submissions for assigned projects including 510(k) and device combination products.
• Knowledge of FDA and FTC labeling, MSDS standards, CPSC, and EPA requirements
• Knowledge of technical standards and GMP

Travel requirements as needed by the BA to fulfill the obligations of the position

About the Company:

Trelleborg Medical Solutions partners with the world’s leading medical device and biopharmaceutical companies, collaborating from concept to commercialization to bring to market impactful solutions that improve patient quality of life. It leverages decades of design and manufacturing experience, in-depth knowledge of polymer materials and a deep understanding of customer applications and end-use environments to deliver pioneering, engineered solutions for transformative health technologies. Utilizing its global quality system and engineering and manufacturing network, the company is a production partner of choice for medical devices and biopharmaceutical companies.

#TMS

All qualified applicants will receive consideration for employment without regard to the individual's race, color, sex, national origin, religion, age, disability, genetic information, status as a military veteran or any other characteristic protected by applicable law.

Apply here!

Imagine leveraging your 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 Assurance and Regulatory Director - Americas, based from their Minneapolis MN headquarters. 

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

• Competitive compensation: $160-180,000 DOE + 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 have the autonomy and support to lead the production team and impact the production of life-saving devices.
• Growth and advancement: Join a global company that loves to promote from within and allows for advancement into one of their many other U.S. locations!

Tasks and Responsibilities

• Own and govern the effectiveness of the Americas Quality Management System in compliance with ISO 13485, FDA QSR, and applicable international standards.
• Serve as delegated ISO 13485 Management Representative and report on QMS effectiveness to executive management.
• Define and execute regional regulatory strategy aligned with global business objectives.
• Oversee product/material registrations, listings, certifications, and technical documentation throughout the product lifecycle.
• Lead inspection readiness and act as primary interface with FDA, Notified Bodies, and international regulatory authorities.
• Oversee vigilance, medical device reporting, recalls, and field actions across the Americas.
• Drive operational quality excellence through CAPA, nonconformance management, and continuous improvement initiatives.
• Serve as senior quality interface for key customers, supporting audits and quality agreements.
• Lead, develop, and mentor a regional team of quality and regulatory professionals.
• Ensure training and competency development for quality systems across regional operations.
• Maintain regulatory intelligence and proactively assess impact of regulatory changes.
• Periodically benchmark cost of quality operations with industry peers.

Education and Experience

• Bachelor’s degree in engineering, Life Science, or related technical field; Master’s preferred.
• 10+ years of progressive experience in Quality Assurance and/or Regulatory Affairs; 5 years within the medical device industry.
• Demonstrated leadership experience in a global, matrixed organization.

Competencies

• Expert knowledge of FDA QSR, 21 CFR (801, 803, 806, 807, 820), ISO 13485, ISO 14971, MDR/MDD.
• Strong regulatory intelligence and risk-based decision making skills.
• Ability to manage multiple priorities and lead through influence.
• Excellent written, verbal, and executive communication skills.

Geography and Travel Requirements

• Regional to the Americas (North, South and Central)
• Must be accessible to a major airport
• Travel expected up to 50%

#TMS

About the Company:

Trelleborg Medical Solutions partners with the world’s leading medical device and biopharmaceutical companies, collaborating from concept to commercialization to bring to market impactful solutions that improve patient quality of life. It leverages decades of design and manufacturing experience, in-depth knowledge of polymer materials and a deep understanding of customer applications and end-use environments to deliver pioneering, engineered solutions for transformative health technologies. Utilizing its global quality system and engineering and manufacturing network, the company is a production partner of choice for medical devices and biopharmaceutical companies.

Apply here!

What you´ll do: 

Imagine working for one of the leading contract manufacturers in the world. Trelleborg Medical Solutions is located 30 miles from California’s pristine Central Coast. As a premier manufacturer for life-saving medical components, Trelleborg Medical Solutions is a forward-thinking company. We have been active in our lean manufacturing journey for many years and are advancing towards making our business a showcase of excellence in the medical industry.

Seize this rare opportunity to be part of a healthcare and medical business unit that has been in business for over 100 years, all while enjoying the benefits of living in one of California’s most desired locations!

About the Job

Trelleborg Medical Solutions is seeking a Quality Engineer. In this role, you will be 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.  

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.

Education and Experience: 

• 4 year degree in quality, engineering or any 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 Trelleborg team member, you will enjoy:

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

#TMS

Salary range:  $87,000-$100,000

APPLY HERE!

Summary of the Role: 

Quality Engineers have the technical ability and expertise to solve complex problems. Problems can be either technical, with regards to product quality, or commercial, regarding processes. Both types of problems need specialized abilities to determine the root cause so that they can be resolved. Many quality functions, such as auditing or PPAP/FAIR need technical training and understanding of the applicable standards.

Tasks and Responsibilities: 

Summary of the Role: 

Quality Engineers have the technical ability and expertise to solve complex problems. Problems can be either technical, with regards to product quality, or commercial, regarding processes. Both types of problems need specialized abilities to determine the root cause so that they can be resolved. Many quality functions, such as auditing or PPAP/FAIR need technical training and understanding of the applicable standards. 

Tasks and Responsibilities:  

Do you approach new challenges with passion and take responsibility for your actions?

Be the change you want to see and start shaping industry from the inside.

About us

Trelleborg is a world leader in engineered polymer solutions for almost every industry in the world. And we are where we are because our talents brought us here.

At Trelleborg Marine & Infrastructure, we go beyond service, building lasting partnerships with engineers, contractors, and owners to deliver long-term solutions that make a real impact.

About the role

As the Quality Manager you will be responsible for defining, maintaining, and independently verifying product, process, and system quality across the organization. You will own the Quality Management System (QMS), ensure compliance with customer, regulatory, and internal requirements, and provide objective oversight of manufacturing activities. You will operate independently of production priorities and has authority over audits, nonconformance management, corrective actions, and product acceptance decision.

Your Responsibilities

• Own and maintain the Quality Management System (QMS) and related documentation
• Define quality standards, inspection criteria, control plans, and acceptance requirements
• Lead internal, external, customer, and regulatory audits
• Own the nonconformance, CAPA, and preventive action processes, including effectiveness verification
• Perform and validate root cause analysis for quality issues
• Oversee inspection, testing, and quality data analysis
• Manage supplier quality requirements, audits, and escalations
• Drive quality-focused continuous improvement initiatives
• Train employees on quality standards, procedures, and compliance expectations

What you bring

• Bachelor’s degree in Quality, Engineering, Manufacturing, or related discipline
• 5–10 years of experience in quality management within a manufacturing environment
• Experience with ISO or equivalent quality systems and customer audits
• Prior leadership or supervisory experience preferred.
• Chemistry or Chemical industry experience preferred.

Desired Competencies

• Quality management systems expertise
• Root cause analysis and problem-solving
• Audit leadership and regulatory knowledge
• Data analysis and risk-based thinking
• Clear, assertive communication
• Ability to operate independently and objectively

Traits we value

• High integrity and independence
• Detail-oriented and analytical
• Confident in escalation and decision-making
• Structured, methodical, and disciplined
• Collaborative while maintaining objectivity

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

Sound like the ideal environment for you?

Don't delay, apply now to shape your career at Trelleborg.

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 colleagues.

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

At Trelleborg our people are #shapingindustryfromtheinside

The Quality & HSE Manager is responsible for all activities related to quality and occupational safety within the site, as well as for developing, implementing, and continuously improving the company’s Quality Management System and Health, Safety & Environment programs. This role ensures compliance with all relevant standards, regulations, and corporate policies, while fostering a culture of continuous improvement, operational excellence, and safe working practices across the organization.

📍 Location: ITA – Torino (Pianezza).

Key Responsibilities

Quality Management

• Develop, maintain, and improve the Quality Management System in accordance with applicable standards (ISO 9001, IATF 16949, EN9100).
• Lead internal and external audits, manage corrective and preventive actions, and ensure timely closure of findings.
• Monitor quality performance metrics and drive continuous improvement initiatives.
• Manage product non-conformities, root-cause analysis, and cross-functional problem solving. Liaise with internal and external customers.
• Oversee supplier quality performance and coordinate supplier audits and evaluations.
• Ensure documentation control, versioning, and compliance across the organization.

Health, Safety & Environment (HSE) / RSPP

• Nominated RSPP
• Develop and implement HSE policies, standards, and procedures aligned with legal requirements and in accordance with applicable standards (ISO 45001, ISO 14001).
• Conduct risk assessments, safety inspections, incident investigations, and safety drills.
• Promote a strong safety culture and ensure engagement of all employees.
• Monitor and report HSE KPIs, ensuring compliance with applicable regulations.
• Manage waste disposal, environmental monitoring, and sustainability initiatives.
• Liaise with regulatory bodies, certification authorities, and external stakeholders.
• Coordinate training on safety practices, emergency response, and environmental awareness.

Leadership & Cross-Functional Collaboration

• Lead and mentor the Quality & HSE team, ensure adequate training.
• Work closely with other company departments to ensure integrated compliance.
• Drive continuous improvement programs.
• Act as the key point of contact for all quality and HSE communication internally and externally.

Qualifications & Experience

Education

• Bachelor’s or Master’s degree in Engineering.

Professional Experience

• 3-5 years in a Quality and HSE role, ideally in manufacturing, industrial, or technical environments.
• Experience with ISO management systems (ISO 9001, IATF16949, ISO 14001, ISO 45001).
• Proven record of conducting audits and managing certification processes.
• RSPP Certification already available is a plus

Skills & Competencies

• Strong knowledge of automotive quality tools and methodologies (FMEA, PPAP, SPC, APQP, MSA, root cause analysis, problem solving/8D).
• Good understanding of occupational safety laws and environmental regulations.
• Excellent communication, leadership, and training abilities.
• Fluent in Italian and English.
• Analytical, detail-oriented, and proactive mindset.
• Ability to manage multiple priorities and influence cross-functional teams.
• Certifications such as VDA6.3 Auditor and Six Sigma are a plus.

Our benefits for You:

• A modern multicultural work environment.
• Several weeks of induction training for your new tasks, where you will get to know our company, your contacts, and our structures.
• An exciting, multifaceted, and interdisciplinary field of activity.
• Extensive product training.
• Flexible office hours with remote work opportunities.

Why join Us?

• Opportunity to drive real impact in a fast-paced manufacturing environment.
• Work in an innovative and encouraging team.
• Career growth and professional development opportunities.
• Be part of a company that values continuous improvement and sustainability.

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 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.

Wir suchen eine fachspezifisch qualifizierte Persönlichkeit im Bereich Qualitätssicherung, idealerweise mit fundierten Kenntnissen in ISO 13485 und/oder IATF 16949 sowie mehrjähriger Erfahrung in der industriellen Qualitätsarbeit – bevorzugt im Spritzgussumfeld.

Qualitätstechniker Technische Produktion (m/w/d)

Hauptaufgaben und Verantwortlichkeiten:

• Du bist einer der Qualitätstechniker für Prozessplanung, pFMEA und APQP – stets in Übereinstimmung mit den Anforderungen aus ISO 13485 und/oder IATF 16949.
• Du bist zentraler Ansprechpartner für interne und externe Kunden in allen qualitätsrelevanten Themen rund um die dir zugewiesenen Produkte.
• Du führst Erstbemusterungen nach normenkonformen Vorgaben durch und erstellst vollständige, nachvollziehbare Erstmusterprüfberichte.
• Du arbeitest an Validierungen gemäss Vorlagestufen und Kundenanforderungen und beherrschst die Validierungs‑Systematik (Prozessvalidierung, DQ, IQ, OQ, PQ) sowie – sofern zutreffend – die IATF‑Anforderungen (z. B. PPAP Level 3).
• Du führst Serienfreigaben durch und übernimmst die Serienüberwachung, um sicherzustellen, dass Produktion und Produkte jederzeit normkonform sind und sämtliche Kundenanforderungen erfüllen.
• Du verantwortest die 8D‑Reklamationsbearbeitung nach strukturiertem, normgerechtem Vorgehen.
• Du führst Fehleranalysen durch (z. B. Ishikawa, 5‑Why, DOE), leitest geeignete Massnahmen ab, stellst deren Umsetzung sicher und überprüfst deren Wirksamkeit (Effectiveness Check) – ein zentraler Bestandteil beider Normen.
• Du koordinierst Korrektur- und Vorbeugemassnahmen (CAPA) entsprechend den normativen Vorgaben.
• Du unterstützt den Leiter Qualität bei internen und externen Audits, einschliesslich Vorbereitung, Dokumentation und Nachverfolgung von CAPA‑Massnahmen.

Ihr Profil:

• Technische Grundausbildung, z. B. als Kunststofftechnologe, Werkzeugmacher, Mechaniker oder Feinmechaniker.
• Weiterbildung im Bereich Qualitätssicherung.
• Vertiefte Kenntnisse der gängigen QS‑Tools: FMEA, APQP/PQP, Statistik, 8D, CAPA, Fehleranalyse.
• Erfahrung in der Qualitätssicherung, idealerweise in der Massenproduktion und/oder im Spritzguss.
• Gute bis sehr gute Kenntnisse in ISO 13485 und/oder IATF 16949.
• Sehr gute Deutschkenntnisse sowie sichere Englischkenntnisse auf gutem Niveau.

Wir bieten:

• Ein abwechslungsreiches und verantwortungsvolles Aufgabenfeld
• Moderne Infrastruktur und ein erfahrenes, kompetentes Team
• Flache Hierarchien und kurze Entscheidungswege
• Hoher Gestaltungsspielraum und echte Eigenverantwortung
• Eine offene Unternehmenskultur mit Raum für eigene Ideen
• Eine gründliche, strukturierte und professionelle Einarbeitung

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

Summary of the Role: 

Quality Engineers have the technical ability and expertise to solve complex problems. Problems can be either technical, with regards to product quality, or commercial, regarding processes. Both types of problems need specialized abilities to determine the root cause so that they can be resolved. Many quality functions, such as auditing or PPAP/FAIR need technical training and understanding of the applicable standards.

Tasks and Responsibilities: 

• Partner with customers to understand their QA needs and provide solutions
• Complete customer complaints with customer and suppliers
• Complete plans for standard products and provide to customers and suppliers
• Lead and create internal and external trainings as subject matter expert
• Collaborate with cross-functional teams to ensure customer satisfaction
• Review FAIS from factory and send to customers
• Manage customer portals
• Perform and support internal AS9100 audits
• Partner with suppliers as needed to support inspection gaps
• Experience completing PPAP/FAI required

Education and Experience: 

• Bachelor’s degree in engineering or other technical discipline
• 3 years’ experience in an engineering role, preferably in a manufacturing role
• Master’s degree counts towards 2 years’ experience
• 2 years’ experience in quality including experience with complex surfaces and assemblies
• Knowledge of aerospace processes, such as AS9100
• Proficiency in Microsoft Word and PowerPoint

Competencies: 

• Strong analytical, decision making and problem-solving skills
• Strong mechanical and technical aptitude
• Ability to self-manage and successfully work without supervision
• Ability to handle and prioritize dynamic workload
• Strong oral and written communication skills
• Excellent organization skills
• Proven proficiency with presentations and public speaking

The final compensation offered to the candidate may be based on geographical location, work experience and/or skill level. Additions to the compensation packing, including but not limited to paid time off, insurance benefits and 401(k) eligibility, will be outlined at the time of the job offer.

Compensation range: $75,000-$105,000

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
Vision insurance

Application: 

Apply here!

Last Application Date 7/18/2026

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.