Quality Operations Manager - Medical Devices

PROJECTUS; Grenoble; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

PROJECTUS in Grenoble, France, is seeking a Quality Manager for Medical Devices. The role ensures products are safe and compliant before market release, with authority to release or block products and approve sterilization certificates.

The role includes validating qualification/validation activities, supporting CAPA and change control, and leading a quality/metrology team to maintain ISO 13485 and regulatory alignment.

Qualifications

• Master’s degree in science or engineering
• 3+ years in pharmaceutical or medical device quality operations
• Strong knowledge of ISO 13485, ISO 14971, MDR, and FDA 21 CFR 8
• Experience with sterilization validation, risk analysis, CAPA, and quality systems
• Analytical, communication, leadership, and decision-making skills
• Fluent technical English and strong collaboration abilities

Responsabilités

• Manage document control, batch review, and product release activities
• Ensure compliance with ISO 13485, MDR, FDA QSR, and related quality standards
• Oversee metrology systems and management of measurement/testing equipment
• Support non-conformance, CAPA, deviation, OOS/OOT, and change control processes
• Approve validation, qualification, and quality documentation
• Collaborate cross-functionally with Production, Engineering, Supply Chain, R&D, and Quality teams
• Participate in audits as a technical quality expert
• Lead and develop the quality/metrology team, including performance management, training, and recruitment

Description du poste

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