Quality Engineer – Medical Devices

About the role

Vygon is seeking a Quality Engineer to support its medical‑device production sites. You will ensure that all quality processes are effective, from design through distribution, and help maintain compliance with regulatory standards.

Key responsibilities

• Manage the Corrective and Preventive Action (CAPA) process, monitor action plans and update key performance indicators.
• Lead investigations of customer complaints using problem‑solving tools such as 8D, 6M and the 5 Whys.
• Oversee surveillance plans in line with current procedures.
• Participate in internal, customer and regulatory audits and assist in preparing and updating quality documentation.

Required profile

• Strong knowledge of ISO 13485 and experience with Lean and Six Sigma methodologies.
• Proficiency in project management, PDCA cycles and KPI monitoring.
• Analytical and synthesis abilities with a focus on continuous improvement.
• Fluency in French and English.

Required skills

• ISO 13485
• Lean
• Six Sigma
• 8D problem‑solving
• 6M analysis
• 5 Whys technique
• PDCA methodology
• KPI monitoring
• Project management

What we offer

• Opportunity to work in an international, family‑owned company with a strong focus on quality and patient safety.
• Collaborative environment that values integrity, commitment and continuous improvement.