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 a training in quality management Confirmed experience in quality assurance in a Medtech production environment Experience in team management and marked 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 of Lean Management Secure communication with internal departments, customers and suppliers Good mastery of MS Office, experience CAQ/ERP Languages: French and German = current; English = good level The advantages: A key position with global quality responsibility on two sites An international Medtech environment, demanding and oriented towards continuous improvement An open culture, quick decisions and an open-door philosophy Opportunities for individual development 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 for medical technologies, is looking for a Quality Manager for two sites in French-speaking Switzerland. You will play a key role in driving 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 ensure global responsibility for local quality activities Maintain and improve the QMS according to ISO 13485, FDA 21 CFR Part 820 and applicable regulations Drive internal audits, customer and notified bodies, from preparation to follow-up of actions Be the main contact person for customers, authorities, notified bodies and partners on quality issues 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 budget Support Regulatory Affairs activities jpid7d6fc20jm jpit0627jm jpiy26jm