Quality Manager - Medtech - GER / ENG / FR

Mandated by one of our clients, we are looking for a:br/br/Quality Manager - Medtech - GER / ENG / FRbr/br/Higher technical education (ES/HES), complemented by training in quality management Proven experience in quality assurance within 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 is an asset Training or good knowledge in Lean Management Confident communication with internal departments, clients and suppliers Good command of MS Office, experience with CAQ/ERP Languages: French and German = fluent; English = good levelbr/br/The benefits:br/br/A key position with overall quality responsibility across two sites An international Medtech environment, demanding and focused on continuous improvement An open culture, quick decisions and an open-door philosophy Opportunities for individual development 6 weeks’ holiday, attractive social benefits, team events and loyalty bonuses Our client, an international company active in the development and manufacture of solutions for medical technologies, is seeking a Quality Manager for two sites in French-speaking Switzerland. You will play a key role in managing the quality system, leading the QA team and driving continuous improvement.br/br/Act as Quality Management Representative for the certified and harmonised QMS across 2 sites Manage the QA team of both sites and ensure overall responsibility for local quality activities Maintain and improve the QMS according to ISO 13485, FDA 21 CFR Part 820 and applicable regulations Lead internal, client and notified body audits, from preparation to follow-up actions Be the main contact for clients, authorities, notified bodies and partners on quality matters Oversee 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 budget Support Regulatory Affairs activitiesbr/br/jid9bc7dd8aen jit0832aen jpiy26aen