Quality Engineer

Quality Engineer - Medical Devices
Location: North of Paris | On-site: 5 days/week | English & French Language

We're supporting a leading medical device manufacturer in the North of Paris who are seeking an experienced Quality Engineer to join their team.

Key Responsibilities:

• Act as the Quality interface with Production, Industrialization & R&D
• Manage non-conformities and deviations, leading investigations and CAPAs
• Drive continuous improvement across quality processes
• Review/approve equipment qualification and process validation documents
• Support risk analyses, change control, and MDR/MDD transition activities
• Contribute to audit preparation and act as SME when needed
• Promote Quality culture and deliver training on NC management

Requirements:

• Master's degree in Engineering, Pharmacy, or related scientific field
• 5+ years' industry experience (medtech, pharma, automotive, aero, etc.)
• Strong knowledge of ISO 13485, ISO 14971, 21 CFR 820 and QMS principles
• Skilled in investigations, validation, and Q/V tools
• English fluency; sterilisation/CSV knowledge a plus
• Car required due to site location