Regional Quality Manager – Europe

About the role

The Regional Quality Manager for Trelleborg Medical Solutions (Europe) leads and continuously improves the Quality Management System across European sites, ensuring regulatory compliance and operational excellence in line with the global quality strategy.

Key responsibilities

• Lead and maintain the regional QMS, standardising processes and ensuring compliance with FDA, MDR, IVDR and other regulations.
• Provide quality leadership for the Stein am Rhein facility and oversee European quality teams, driving continuous improvement and integration of acquisitions.
• Serve as the primary quality contact for customers, support audits, manage supplier quality and lead CAPA processes.
• Champion AI‑enabled and digital quality solutions, leveraging data analytics to identify trends and improve decision‑making.

Required profile

• 10+ years of quality management experience in a regulated manufacturing environment.
• 5+ years of leadership experience managing multi‑site quality organisations.
• Strong knowledge of FDA Quality System Regulations and European medical device regulations (MDR/IVDR).
• Experience with acquisitions, QMS integration and matrixed global organisations.

Required skills

• FDA Quality System Regulations
• MDR / IVDR compliance
• CAPA management and internal audits
• Supplier quality management
• Data analytics and AI‑enabled digital quality tools

What we offer

• Modern, engaging work environment with growth and continuous learning opportunities.
• International collaboration, flexible and remote work options.
• Participation in impactful projects contributing to digital transformation and sustainability.