Quality Engineer (m/w/d) – Validation, FMEA & Regulatory Compliance, Medical Devices

Becton Dickinson; Vilters-Wangs; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

BD in Switzerland is seeking a Quality Engineer to drive compliance and robust validation in a highly regulated medical device environment. You will contribute to risk management, CAPA, and continuous improvement on cross‑functional teams in Wangs.

The role requires hands‑on IQ/OQ/PQ validation, knowledge of ISO 13485, ISO 14971/24971, and fluency in German and English. A strong analytical mindset and collaborative spirit are essential for success.

Qualifikationen

• Bachelor's degree in engineering.
• Experience in the medical device industry or a regulated environment.
• Knowledge of ISO 13485, ISO 14971/24971, EU MDR.
• Hands-on experience with IQ/OQ/PQ validation, statistical tools and CAPA.

Aufgaben

• Quality & Compliance: support all quality development activities for commercial production.
• Ensure compliance with internal procedures, FDA regulations, and applicable international standards (ISO 13485, EU MDR, ASTM).
• Serve as quality subject matter expert during regulatory and internal audits.
• Validation & Process Qualification: support validation and re‑validation of test methods and manufacturing processes.
• Develop, review, and approve protocols and reports for test method validation.
• Implement IQ, OQ and PQ process qualification activities, including protocol and report review.
• Risk Management: cross‑functionally collaborate on FMEAs (design, production, user).
• Create, maintain, and approve risk management documents in line with ISO 14971/24971.
• CAPA: lead root-cause analysis and corrective/preventive action implementation.
• Perform statistical analyses to determine process capability using Minitab and DOE.
• Support Manufacturing Engineering across quality-related tasks.

Kenntnisse

German language

English language

Quality engineering

Regulatory compliance

IQ/OQ/PQ validation

FMEA

Data analysis

Multidisciplinary collaboration

Ausbildung

Bachelor's degree in engineering

Tools

Minitab

DOE

MS Office

Jobbeschreibung

Job Description

We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

About the Role

Are you a quality-driven engineering professional with a passion for precision, compliance, and making medical technology safer? We are looking for aQuality Engineer (m/w/d)to join our multidisciplinary team inWangs, Switzerland, supporting validation, risk management, and quality assurance activities within a highly regulated medical device manufacturing environment. This role sits at the intersection of engineering rigour and regulatory compliance — ideal for professionals with hands‑on experience inprocess validation (IQ/OQ/PQ),risk management (FMEA, ISO 14971), andquality systems (ISO 13485, EU MDR). We also welcome applications from professionals with backgrounds inSterilization ValidationandQuality &Regulatory Affairs.

What You Will Do

• Quality & Compliance Support all quality development activities for commercial production
• Ensure compliance with internal procedures,FDA regulations, and applicable international standards(ISO 13485, EU MDR, ASTM)
• Serve as quality subject matter expert during regulatory and internal audits
• Validation & Process Qualification Support validation and re‑validation of test methods and manufacturing processes
• Develop, review, and approveprotocols and reportsfor test method validation
• ImplementIQ, OQ and PQprocess qualification activities, including protocol and report review
• Risk Management Cross‑functionally collaborate with Manufacturing Engineering onFMEAs(design, production, user)
• Create, maintain, and approverisk management documentsin line withISO 14971 / 24971
• Continuous Improvement &Problem Solving Lead and supportCAPAprocesses: root cause analysis, problem‑solving methodologies, and corrective/preventive action implementation
• Performstatistical analysesto determine process capability indicators using tools such asMinitabandDOE (Design of Experiments)
• Support the Manufacturing Engineering team across all quality-related tasks

What You Bring

• Education: Bachelor's degree in an engineering discipline(preferably Mechanical, Process, Materials Science, Chemical, or Pharmaceutical Engineering)
• Experience & Knowledge: Experience in themedical device industryor a comparable regulated environment
• Practical knowledge of global MedTech standards:ISO 13485, ISO 14971/24971, EU MDR
• Hands‑on experience with validation activities(IQ/OQ/PQ), statistical tools and CAPA processes
• Skills: Fluent in German and English— both written and spoken(mandatory)
• Strong analytical and problem‑solving skills
• High level of accuracy and process‑oriented working style
• Proficient inMS Office(especially Word)
• Knowledge ofDOEandMinitabstatistical software
• Collaborative mindset — comfortable working in multidisciplinary, international teams

Why Join Us

Work in a state‑of‑the‑art MedTech environment in Switzerland. Be part of a cross‑functional team where your quality expertise drives real patient impact. Grow within a culture that values precision, accountability, and continuous improvement. Engage with international standards and global regulatory frameworks on a daily basis.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive. We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face‑to‑face collaboration supports your learning, your progress, and your success. To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Required Skills Optional Skills

Primary Work Location CHE Wangs - Straubstrasse. Additional Locations Work Shift CH STR Mgrs-Admins (Switzerland)

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance‑based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You." Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed. Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state‑of‑the‑art technology and cutting‑edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.