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

BD; Vilters-Wangs; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

BD in Wangs, Switzerland, is seeking a Quality Engineer (m/w/d) to join a regulated medical device manufacturing team focused on validation, risk management, and quality assurance activities.

You will apply IQ/OQ/PQ, FMEA, ISO 13485, and EU MDR knowledge; collaborate with cross-functional teams; support audits and CAPA; and bring fluent German and English to ensure rigorous quality standards.

Qualifikationen

• Bachelor’s degree in an engineering discipline (preferably Mechanical, Processing, Materials, Chemical or Pharmaceutical Engineering).
• Experience in the medical device industry or a regulated environment.
• Hands-on validation experience (IQ/OQ/PQ), statistical tools and CAPA processes.

Aufgaben

• Support quality development activities for commercial production.
• Ensure compliance with internal procedures, FDA regulations, ISO 13485 and EU MDR.
• Serve as quality SME during regulatory and internal audits.

Kenntnisse

Quality Assurance

GxP & Regulatory

IQ/OQ/PQ

FMEA

ISO 13485

EU MDR

German & English

Risk Management

Analytical Skills

Ausbildung

Bachelor's degree in engineering

Tools

Minitab

DOE

Jobbeschreibung

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.

Job Description

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 in Wangs, 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 in Sterilization Validation and Quality & 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 standardsISO 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 with Manufacturing Engineering on FMEAs (design, production, user)
• Create, maintain, and approve risk management documents in line with ISO 14971 / 24971

Continuous Improvement & Problem Solving

• Lead and support CAPA processes: root cause analysis, problem-solving methodologies, and corrective/preventive action implementation
• Perform statistical analyses to determine process capability indicators using tools such as Minitab andDOE (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 the medical device industry or 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 in MS Office (especially Word)
• Knowledge of DOE and Minitab statistical 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

Why Join Us?

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

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Primary Work Location

CHE Wangs - Straubstrasse

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