Ingénieur qualité​/Ingénieure qualité

Responsible for packaging documentation activities for medical devices within the R&D team, ensuring compliant and accurate documentation for traumatology and extremities products throughout the product lifecycle.

• Preparation, review, and maintenance of packaging specifications, drawings, and technical documentation
• Ensure compliance with applicable regulations and standards (ISO 13485, EU MDR/IVDR, FDA)
• Manage document changes, version control, and traceability in PLM/QMS systems
• Collaborate with R&D, Quality, Regulatory Affairs, and Operations
• Contribute to packaging verification and validation activities (test protocols, reports)
• Support audits and inspections from a documentation perspective
• Ensure consistency and quality of documentation across projects

• Engineering or scientific degree (biomedical, materials, mechanical or equivalent)
• 5+ years of experience in medical device packaging, documentation, or R&D
• Experience with design control and technical documentation

• Good knowledge of ISO 13485, EU MDR/IVDR, and FDA requirements
• Understanding of medical device packaging (sterile barrier systems, labeling, transport validation)
• Experience with PLM and/or QMS systems
• Fluent in English (French and/or German is an asset)
• Structured, detail-oriented, and reliable
• Able to work independently and in cross-functional teams