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.

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 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
.

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 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 and
  DOE (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 Med Tech 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 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…