Director, Quality Assurance EMEA

About the role

As the Quality Director for Hologic EMEA, you will lead the regional Quality Management System, ensuring compliance with global and regional regulations while driving continuous improvement across multiple markets.

Key responsibilities

• Lead, mentor and develop the EMEA Quality team, fostering cross‑border collaboration.
• Ensure QMS alignment with ISO 13485, 21 CFR, MDR/IVDR, UK CA Marking and related standards.
• Partner with Regulatory, Operations, R&D, Supply Chain, Legal and Commercial teams to harmonise quality processes.
• Drive Lean, Six Sigma and data‑driven initiatives for non‑conformances, CAPAs, complaints and post‑market surveillance.
• Act as primary liaison with regulatory authorities, notified bodies and auditors across EMEA.
• Identify and mitigate quality risks, staying ahead of regulatory changes.
• Provide annual GMP and audit‑readiness training.

Required profile

• Proven experience in medical‑device quality management within EMEA.
• Bachelor’s degree in engineering or related field; Master’s preferred.
• Demonstrated success managing large, multicultural teams.
• Strong analytical, strategic thinking and communication skills.
• Fluency in English; additional languages a plus.

Required skills

• ISO 13485
• 21 CFR
• MDR / IVDR
• Lean
• Six Sigma
• GMP

What we offer

• Opportunity to impact millions of lives by ensuring the highest quality standards.
• Leadership role in a global, innovative healthcare company.