Quality Manager - Medtech - GER / ENG / FR

Quality Manager - Medtech - GER / ENG / FR

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Mandated by one of our clients, we are looking for a:
Quality Manager - Medtech - GER / ENG / FR
- 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 advantage - 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 level
The benefits:
- 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 of 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.
- Ensure the role of Quality Management Representative for the certified and harmonised QMS across 2 sites - Manage the QA team of both sites and guarantee 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 - 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
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