Quality Assurance Officer
Full-timeHybridIn English
About the job
SkinVision, a vibrant scale-up in Amsterdam, is looking for a Quality Assurance Officer to own and improve its Quality Management System for ISO 13485 and SaMD. In this hybrid role, you will manage audits, CAPA processes, and risk management while collaborating with an international team.
What you will do
- Own and improve the Quality Management System for ISO 13485 and SaMD
- Plan and lead internal audits, support external audits
- Maintain MDSAP certification and coordinate audit cycles
- Manage CAPA process from root cause to closure
- Handle non-conformities and complaints with trend analysis
- Collaborate on risk management per ISO 14971
What you bring
- Bachelor's or Master's in Life Sciences, Biomedical Engineering, Quality Management or related
- At least 5 years of Quality Assurance experience in medical devices, SaMD or regulated environment
- Proven experience with QMS under ISO 13485
- Experience with notified body and MDSAP audits
- Fluent in English
Nice to have
- Experience with FDA regulations like 21 CFR 820
- Familiarity with ISO 14971 and IEC 62304
What you get
- Competitive salary
- Additional benefits
- Hybrid working policy
- International team
- Regular team events and off-sites
About SkinVision
SkinVision is a vibrant scale-up in Amsterdam with an international team.
Summary by Personeel.com. The full job description and the application form are on SkinVision's website (careers.skinvision.com); Apply takes you straight there.