Quality Manager - Medtech - ALL / ANG / FR

Mandated by one of our clients, we are looking for a: Quality Manager \- Medtech \- ALL / ANG / FR Mandated by one of our clients, we are looking for a: Quality Manager \- Medtech \- ALL / ANG / FR Higher technical education (ES/HES), completed by training in quality management Proven experience in quality assurance in a Medtech production environment Experience in team management and a strong interest in technical subjects Good knowledge of ISO 13485, FDA 21 CFR Part 820, CAPA, audits and change management Experience in Regulatory Affairs \= an asset Training or good knowledge in Lean Management Confident communication with internal departments, clients and suppliers Good command of MS Office, CAQ/ERP experience Languages: French and German \= fluent; English \= good level The advantages: A key position with global quality responsibility across two sites An international Medtech environment, demanding and oriented towards continuous improvement An open culture, fast decisions and an open\-door philosophy Individual development possibilities 6 weeks of vacation, attractive social benefits, team events and loyalty bonuses Our client, an international company active in the development and manufacture of solutions intended for medical technologies, is looking for a Quality Manager for two sites in French-speaking Switzerland. You will play a key role in steering the quality system, managing the QA team and continuous improvement. Ensure the function of Quality Management Representative for the certified and harmonized QMS on 2 sites Manage the QA team of the two sites and guarantee the global responsibility of local quality activities Maintain and improve the QMS according to ISO 13485, FDA 21 CFR Part 820 and applicable regulations Steer internal, client and notified body audits, from preparation to follow-up of actions Be the main interlocutor for clients, authorities, notified bodies and partners on quality subjects Supervise key QA processes: complaints, CAPA, change management and audit management Monitor quality KPIs, report QMS performance to management / Global QA and drive continuous improvement Manage QA resources, team leadership and the budget Support Regulatory Affairs activities jpid3b7885ejm jpit0730jm jpiy26jm