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Quality Manager (80-100% FTE)

Elos Medtech · Région métropolitaine de Berne

Nouveau
Senior 🇬🇧 English
ISO 13485 FDA 21 CFR Part 820 ERP systems MS Office

Description du poste

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.

Questions fréquentes

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Elos Medtech

Région métropolitaine de Berne