Quality Operations Manager - Medical Devices

Quality Manager - Medical Devices

• Greater Grenoble Metropolitan Area
• Permanent contract
• Salary and package: Available upon discussion with Projectus Consulting

The Quality Manager is responsible for ensuring medical device products are safe and compliant before market release. The role includes authority to release or block products, validate sterilization certificates, approve qualification/validation activities, and support operational quality processes

Key Responsibilitie

• s:Manage document control, batch review, and product release activitie
• s.Ensure compliance with ISO 13485, MDR, FDA QSR, and related quality standard
• s.Oversee metrology systems and management of measurement/testing equipmen
• t.Support non-conformance, CAPA, deviation, OOS/OOT, and change control processe
• s.Approve validation, qualification, and quality documentatio
• n.Collaborate cross-functionally with Production, Engineering, Supply Chain, R&D, and Quality team
• s.Participate in audits as a technical quality exper
• t.Lead and develop the quality/metrology team, including performance management, training, and recruitmen

Skills/Experience require

• d: Master's degree in a scientific or engineering fie
• ld.Minimum 3 years’ experience in pharmaceutical or medical device quality operatio
• ns.Strong knowledge of ISO 13485, ISO 14971, MDR, and FDA 21 CFR 8
• 20.Experience with sterilization validation, risk analysis, CAPA, and quality syste
• ms.Strong analytical, communication, leadership, and decision-making skil
• ls.Fluent technical English and strong collaboration abilit