Responsable Qualité Senior

Our client, a leading group in the field of medical devices, is looking for a Senior QA Manager to join their site located in the canton of Quality Manager. Responsibilities: Act as Quality Management / PRRC of the site. Lead Quality and provide clear direction to the QA team. Ensure excellence across all quality processes: NC / CAPA, Change Control, Risk Management, Complaint Handling. Collaborate closely with site leadership and product managers to deploy tangible quality plans. Develop a quality and GMP culture across the site. Manage and coordinate all internal & external audits (authorities, notified bodies, clients). Drive or actively contribute to quality projects and processes. Network with other Quality Managers in the group to evolve best practices. Bachelor's or Master's degree in biology, pharmaceutical sciences, or a related field. Proven expertise in QMS for medical IVD and standards: ISO, QMSR / 21 CFR 820, MDSAP, IVDD / IVDR. Minimum of 10 years of experience in Quality Assurance in a medtech / healthcare environment, including direct experience in IVD. At least 8 years of successful managerial experience in team development. Recognized leadership, excellent skills, and ability to structure, prioritize, and deliver in a demanding environment. Strong experience in audits and regulatory inspections. Experience in Lean / Six Sigma Green Belt = experience in quality project management. Fluent in French, excellent in English, German appreciated. jid78ad48caen jit0310aen jpiy26aen