Beschreibung
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 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 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’ holiday, attractive social benefits, team events and loyalty bonuses
- 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
- 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 activities