Ingénieur Qualité R&D (Dispositifs Médicaux) F/H/X
Core
R&D Quality Engineer ensuring design control compliance and risk management for new medical device development projects.
Role type
Quality Engineer (Medical Devices)
Builds
Medical device development dossiers (DHF), risk management files, and verification reports.
Domain
Medical Devices / Regulatory Compliance
Deliverable
client delivery
Required skills
Design control, risk management (ISO 14971), DHF construction, design verification, root cause analysis (Ishikawa, 5 Whys), regulatory compliance (ISO 13485, MDR, 21CFR820), supplier testing coordination, change management.
Preferred skills
Plastic injection processes knowledge.
Technologies
None explicitly listed as tools/frameworks.
Responsibilities
Manage quality aspects of new product development projects, ensure traceability of project documentation, conduct risk management sessions, assist in design verification activities, coordinate external laboratory testing, manage design transfer to production, coordinate product change requests, perform internal and external audits.
Seniority
Mid-level (5 years experience required)
