Summary of the Job: 

The Quality Engineer (Part Approval) is an onsite role located in Fort Wayne, IN. The Quality Engineer is responsible for managing customer and supplier part approval documentation required for approval of new part submissions (NPI / APQP), part design and specification changes, and annual part revalidation when required by the Trelleborg Sealing Solutions customer. Represent Supply Chain Management Logistics Center Americas Quality in New Product Introduction (NPI)/Advanced Product Quality Planning (APQP) and other related projects for new products that will flow through LCA. Guide Quality Department members who are supporting customer part approval tasks.

Tasks and Responsibilities: 

• Interact with Sales, Customer Success, Purchasing and other departments in coordinating customer and supplier sample and document submissions through TSS Americas processes and JDE ERP system for part approvals such as PPAP or CCP.
• Prepare, review and approve supplier and customer part approval documents for completeness and accuracy including Process Flow, Control Plan, PFMEA, and other quality related documents.
• Analyze organization dependencies, procedures and training/competence for adequacy.
• Analyze KPIs and other key Characteristics including Measurement System Analysis, Process Capabilities, Run-Charts and other discrete and non-discrete data
• Analyze and assess process flows, and develop new process flow maps where required
• When required, support customer complaint investigation for problem and root cause identification and corrective action implementation and verification.
• Interact with all relevant internal and external stakeholders
• Establish Mistake proofing or Poke-Yoke guidelines for process certification
• Develop Capability controls for process certification
• Establish training requirements for processes and establish control plans

Education and Experience:   

• Bachelor’s degree in engineering or related field required.
• Minimum 3 years quality experience
• Quality management system lead auditor or internal auditor certification (ex. ISO9001:2015, IATF 16949:2016, AS9100D) preferred
• Experience in reading and understanding part drawings and specifications required.
• Experience working in a distribution, manufacturing and/or lean systems environment a plus.
• Experience of understanding and effective use of AIAG Core Tools preferred.
• Experience in sealing applications, rubber, and/or plastics production preferred
• Knowledge of statistics and/or green or black belt in six sigma preferred
• Working knowledge of root cause analysis including related methodologies such as: Ishikawa, 5 Why, 8D, PDCA Kepner-Tregoe, Shainin, and Cause-Effect Diagrams

Competencies:  

• Continuous Improvement
• Poke-Yoke and mistake proofing
• Statistical and analytical skills
• Project Management
• Strong problem solving skills
• Excellent interpersonal and communication skills
• Ability to successfully work independently
• Time management skills, including the ability to meet deadlines.

 Travel:    

• Travel requirements up to 10% per year. 
• The majority of travel, both day trips and over-night, will be visits to support TSS Industrial customers and suppliers in the United States, Mexico and Canada. Candidate must be able to travel outside of the US without restrictions.

Application: 

Apply here!

Last Application Date 9/10/2026

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. 

Trelleborg Medical Solutions is seeking a NPD Quality Engineer to join their team. The NPD Quality Engineer is responsible to plan and coordinate quality engineering activities for medical device manufacturing through the design and development phases including validation for new product development. Collaborate with other 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 team member with Trelleborg, you will enjoy:

• Competitive compensation: $78,000 - $97,000 Annual Salary
• 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.

Pay:

•  $78,000 - $97,000 Annual Salary

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), EU/MDR.

 Responsibilities:

• Knowledgeable and adheres to TMS Quality Management System and its requirements.

• Works with the NPD team to plan, develop and execute equipment, software, test method, and/or process validation strategy

• Monitors and reports out on project deliverables to ensure timely completion; escalates issues, questions, and concerns, immediately to prevent project delays.

• Performs risk management by identifying, estimating, evaluating, controlling, and monitoring risk, utilizing risk tools such as Process Failure Modes and Effects Analysis (pFMEA)

• Authors or approves protocols and reports for Equipment Qualification (IQ/EQ), Software validation (SV), Test Method Validation (TMV), Process validation (OQ/PQ). · Reviews and evaluates specifications, drawings, quality agreements, customer documentation and other documents as necessary to support NPD projects

•  Plans, coordinates, and oversees Test Method Development activities; initiates inspection plans for new/revised product.

•  Works with the Metrology team to recommend equipment, sampling plans, and measurement techniques for inspection specifications

•  Performs measurement system analysis (MSA) Gage 1, Gage Repeatability and Reproducibility (GRR), Bias and Linearity, Resolution and Stability studies

•  Performs statistical analysis of inspection data, process characterization, design of experiments (DOE) results, ANOVA, Capability Analysis

•  Authors and executes Quality Plans, when needed · Support resolution of deviations and nonconforming issues arising during development; completes investigations and perform root cause analysis.

• Reviews and ensures compliance with QMS of all validation documents and records

• Supports Engineering, Manufacturing, and Inspection personnel in design, methods, tooling, validations, and other areas related to the control of product

• Communicates with customers on clarification of specifications, completing customer documents, complaints, process changes, and other projects, as needed. 

• Understands regulatory requirements (e.g. ISO13485, 9001, 14971, FDA 21 CFR 820, EU/MDR, ITAR)

• Provides periodic work direction and assistance to QA inspectors and QE Technicians

• Supports other quality activities such as customer complaints, MRBs, and CAPAs

• Drives best practices through the application of effective quality engineering principles and procedures across functions.

• Supports internal and external audits.

• Other duties as assigned.

Apply here!

#TMS

We are currently looking to recruit a full-time Quality Engineer to join our Quality Department.

As a Quality Engineer, you will be supporting the function of the quality department through the duties outlined below together with any other tasks as assigned by the Quality Manager.

Key Responsibilities:

What we are looking for:
 

• Health Insurance: Private hospital scheme covering the employee, spouse/partner, and children under 21 living at the same address (as per ID card).
• Social and Entertainment Committee: Organizes various activities and awareness initiatives related to well-being, such as Pink October, Movember, Mental Health Awareness, hikes, cultural tours, football matches, voluntary work, Earth Day clean-ups, and more.
• Contingency Fund: Financial support for employees facing health difficulties.
• Training and Development: Includes study leave related to work, graduate programs with soft skills training and site visits, Manufacturing Excellence school, e-learning, Six Sigma Green and Black Belt certifications, etc.
• Performance Appraisal: Annual reviews with potential salary increments based on employee and company performance.
• Engagement Survey: Employees can participate, with results discussed at senior management level and followed by an action plan.
• Work-Life Balance: Flexible working hours plus short Fridays if enough hours are completed during the week.
• Communication: Quarterly townhalls to keep employees informed and engaged.
• Employee Discount Scheme

Summary of the role

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.

Tasks and Responsibilities

• Knowledgeable and adheres to TMS Quality Management System and its requirements.

• Supports internal and external audit program as necessary.
• Supports customer complaint (CC), Non-Conforming (NC) events and materials, and CAPAs 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 NCs
  • 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.
• Authors and executes Quality Plans for Quality Management Systems and Organizational Objectives projects.
• Support TMS projects across sites from Quality perspective, as needed.
• Support Engineering, Manufacturing, NPD, 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.
• Works closely with internal resources to establish processes and resolve issues
• Supports implementation of best practices through the application of effective quality engineering principals and procedures across functions.
• Drives best practices through the application of effective quality engineering principals and procedures across functions.

Education and Experience

Required:

• 4 year degree in quality, engineering or any related field
• 5+ 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), EU/MDR.

Desired:

• Certified Six Sigma Yellow/Green

• ASQ Certified Quality Engineer and/or Auditor and/or equivalent
• Class I, II, and/or III Medical device manufacturing experience

Summary:

An EHS (Environment, Health, and Safety) Coordinator is responsible for planning, implementing, and overseeing an organization's comprehensive safety programs. They work to create a safe work environment, prevent injuries and accidents, and ensure compliance with legal and regulatory standards related to occupational health and safety, fostering a culture of employee well-being and environmental responsibility within the company.

Tasks and Responsibilities

• Implement and maintain ISO45001 (Occupational Health & Safety)
• Conduct Risk assessments and implement preventative measures to minimize workplace hazards.
• Lead the safety committee, conduct environmental and safety training and environmental and safety audits for Trelleborg Aerospace manufacturing sites.
• Evaluate practices, procedures, and facilities to ensure adherence to laws and regulations, developing and implementing relevant policies.
• Conduct training and presentations on health and safety matters and accident prevention to Trelleborg Aerospace manufacturing sites.
• Inspect equipment and machinery to identify potential safety hazards.
• Investigate accidents or incidents, determining causes, and handling worker's compensation claims.
• Prepare and presenting reports on accidents, violations, and trends in accident Statistics. Collect, analyze, and maintain Environmental and Safety Metrics. Includes monthly reporting.
• Conduct both internal and external safety audits to assess compliance and identify areas for improvement.
• Oversee waste management, environmental compliance, and emissions.
• Recommend solutions, improvement opportunities, and new prevention measures.
• Collaborate with other departments to develop and execute business contingency plans.
• Develop & maintain site layout & footprint of site including any in-facility restructuring as the business evolves in alignment with manufacturing operations, define required new machine specifications and coordinate logistics and rigging needs for installation to meet manufacturing demands and customer requirements.
• Manage and maintaining the Environmental Management System (EMS) and related certification, ensuring legislative compliance.
• Ensure compliance with all applicable environmental and safety regulations including hazardous waste management, air and water permitting, SARA, OSHA and applicable European standards.
• Ensure that wastes (hazardous and non-hazardous) are inspected and labeled, and ensure proper disposal procedures are being followed. Act as hazardous waste coordinator.
• Implement and achievement of ISO 14001 and secure certification (Operationally aligned today but not formally certified – in process).
• Corporate responsibility reporting, annual Blue Grading assessment of operations per corporate guidelines in relation to EH&S, local authority & Fire Department coordination/reporting, permit conformance, and coordinate of site security system.

Education and Experience

Required:

• Minimum of a Bachelor’s Degree in Environmental Health & Safety, Engineering or related technical field
• 8+ years of related experience in both facilities/maintenance and EH&S (Environmental, Health and Safety)
• 5+ years experience in a manufacturing environment
• 5+ years experience in a leadership role

Desired:

• Knowledge and experience with GMP/ISO Standards: ISO 9000/9001, ISO 13485, and FDA 21CFR 820/11 (4/210/211 as applicable)
• 3+ years in a maintenance leadership role
• Experience and/or understanding of blueprint reading, general mechanical skills. In addition experience with hydraulic, pneumatic, and electrically controlled and operated systems.

Competencies

• Aligned cooperation with operations management and engineering teams.
• Business and technical acumen a must.
• 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
• Ability to use an MRP system as needed
• Ability to maintain a professional and respectful relationship with coworkers and company in a leadership capacity
• Able to provide compliance guidance based on knowledge of regulations, available relevant information, alternatives, and risk
• Problem solving; Ability to overcome obstacles
• Ability to manage cross-functional teams, coordinate outside vendor meetings
• Ability to influence for impact

Travel: 

• 30%

Compensation range: $105,000-$123,000 per annum

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. 

All applicants must successfully complete a background check and drug screening as a condition of employment.

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.

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!

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

Quality Engineer

Trelleborg Medical Solutions is seeking a Quality Engineer to support the development, implementation, and maintenance of a Quality Management System compliant with FDA regulations and ISO standards. This role partners with cross-functional teams, customers, and suppliers to ensure product quality, regulatory compliance, and continuous improvement. The Quality Engineer will drive quality initiatives for new and existing products, utilizing Lean Manufacturing principles and quality tools to enhance manufacturing, inspection, testing, and labeling processes while supporting operational excellence and customer satisfaction.

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.

Required:

• 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
• Experience with ISO 13485 

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, Project, Access and JMP
• Comprehensive understanding of applicable Work Instructions, SOP’S, 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

 Compensation package range: $90,000-$115,00 DOE

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

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 9/6/2026

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.