Quality Head – Lead Quality Department

About the role

Lead the quality department at the production plant, ensuring that all manufactured devices meet regulatory and customer requirements while driving continuous improvement across the site.

Key responsibilities

• Notify management immediately of reportable quality defects, non‑conformities, complaints, OOX results, or data‑integrity issues.
• Coordinate projects for implementation, improvement and maintenance of the quality system.
• Develop and implement the organization’s binding quality policy and strategy.
• Provide technical and qualitative support to key customers.
• Monitor quality parameters of manufactured devices and ensure compliance with ISO 9001 / ISO 13485.
• Supervise in‑process and final controls before sterilisation and ensure proper documentation.
• Maintain a local QMS in line with the Global Quality Management Handbook and all relevant regulatory requirements.
• Oversee product/batch release, warehousing, storage and distribution to meet global QM documents and marketing authorisations.

Required profile

• Minimum 10 years of QA experience in a regulated industry, with 3‑4 years as a quality director.
• Strong knowledge of ISO 13485, ISO 14971, MDD, EU‑MDR and GxP requirements.
• Fluent in English (spoken and written) and able to communicate at all organisational levels.
• Higher technical education (university degree) and proven experience leading and managing teams.

Required skills

• ISO 13485
• ISO 14971
• MDD
• EU‑MDR
• GxP