Quality Manager (80-100% FTE)
Elos Medtech · Région métropolitaine de Berne
Job description
About the role
Elos Medtech seeks a Quality Manager to lead the Quality Assurance function across its Muntelier and Yverdon‑les‑Bains sites. You will be responsible for maintaining a harmonised Quality Management System that meets ISO 13485, FDA 21 CFR Part 820 and other applicable regulations.
Key responsibilities
- Overall ownership of quality‑related activities at both sites and leadership of the local QA team.
- Implement, maintain and continuously improve the QMS in compliance with ISO 13485, FDA 21 CFR Part 820 and relevant regulations.
- Plan, coordinate and follow‑up internal, customer and notified‑body audits.
- Serve as primary contact for customers, notified bodies, authorities and business partners on quality matters.
- Oversee core QA processes such as complaints handling, CAPA, change management and audit management.
- Report QMS performance and key quality indicators to top management and Global QA, driving improvement initiatives.
- Manage QA resources, including team leadership and budget responsibilities.
- Support Regulatory Affairs on internal projects and customer requests.
Required profile
- Technical background (ES, HES) with further education in quality management.
- Proven experience in quality assurance within MedTech production; regulatory affairs experience is a plus.
- Demonstrated team‑management experience.
- Native French or German speaker with very good command of the other language and English.
- Strong interest in technical topics and good knowledge of MS Office, CAQ and ERP systems.
Required skills
- ISO 13485
- FDA 21 CFR Part 820
- CAQ systems
- ERP systems
- MS Office
What we offer
- Open company culture with short decision‑making processes.
- Six weeks of vacation and attractive social benefits.
- Opportunities for individual development and regular team events.
- Loyalty bonuses.
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Published 1 ora fa
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Elos Medtech
Région métropolitaine de Berne
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