Ingénieur Qualité Expérimenté - Design Control F/H (CDD 6 mois)
Core
Ensure regulatory compliance of Verification & Validation (V&V) activities for medical devices throughout the product lifecycle.
Role type
Senior Quality Engineer (Design Control)
Builds
Implantable biomimetic heart pumps
Domain
Medical device manufacturing / Regulatory Quality
Required skills
Design Control, V&V execution, ISO 13485, FDA 21 CFR Part 820, MDR, ISO 14971 risk management, CAPA management, technical mentoring
Preferred skills
Class III medical device experience, knowledge of ISO 14708-5, ISO 60601 series, ISO 62304, ISO 10993 series
Technologies
Microsoft Office
Responsibilities
Define, write, and approve quality documentation for V&V; ensure traceability between requirements, tests, and acceptance criteria; participate in internal and external audits; manage product risks and non-conformities; technically mentor a senior engineer and support R&D teams.
Seniority
Senior, hands-on IC