This role will act as the technical quality owner during product development, design transfer and post-market support. This includes design control, verification, risk management and manufacturing readiness for both hardware/software, reusable systems and mobile applications. Additional responsibilities include: 

• Review and approve design control documentation across all phases.
• Lead/support usability, mechanical, shelf-life and biosafety testing.
• Ensure V&V strategy meets EU MDR, FDA and risk-based requirements.
• Lead risk management activities (ISO 14971) with engineering
• Collaborate with suppliers and manufacturing partners to define and maintain quality controls. 

 

Requirements:

• Bachelor's degree in Engineering, Quality or Life Sciences.
• 5+ years of Quality Engineering experience in medical devices or regulated industry.
• Strong experience with design control and V&V (including usability, mechanical,shelf-life, biosafety).
• Solid experience with risk management (ISO 14971).
• Familiarity with IEC 60601, ISO 10993.
• Strong documentation and QMS knowledge. 

Offer:

• Join a innovative scale-up environment working with an international team
• Take ownership from day one and directly see the actions of your work
• Modern office with flexible hybrid work pattern
• Competitive benefits package including strong incentives plan