Quality Engineer; m​/w​/d Validation, FMEA & Regulatory Compliance, Medical Devices

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 Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Are you a quality-driven engineering professional with a passion for precision, compliance, and making medical technology safer? We are looking for a Quality 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 in process validation (IQ/OQ/PQ),
risk management (FMEA, ISO 14971), and quality systems (ISO 13485, EU MDR).

We also welcome applications from professionals with backgrounds in Sterilization Validation
and
Quality & Regulatory Affairs
.

• 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

• Support validation and re-validation of test methods and manufacturing processes
• Develop, review, and approveprotocols and reports for test method validation
• ImplementIQ, OQ and PQprocess qualification activities, including protocol and report review

• Cross-functionally collaborate with Manufacturing Engineering onFMEAs(design, production, user)
• Create, maintain, and approverisk management document sin line withISO 14971 / 24971

• Lead and supportCAPAprocesses: root cause analysis, problem-solving methodologies, and corrective/preventive action implementation
• Performstatistical analyses to determine process capability indicators using tools such asMinitabandDOE (Design of Experiments)
• Support the Manufacturing Engineering team across all quality-related tasks

• Bachelor's degree in an engineering discipline(preferably Mechanical, Process, Materials Science, Chemical, or Pharmaceutical Engineering)

• Experience in the medical device industryor a comparable regulated environment
• Practical knowledge of global Med Tech standards:
  
  ISO 13485, ISO 14971/24971, EU MDR
• Hands-on experience with validation activities(IQ/OQ/PQ), statistical tools and CAPA processes

• 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

• Work in astate-of-the-art Med Tech 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…