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 local regulations while driving continuous improvement across multiple markets.

Key responsibilities

• Lead, mentor and develop the EMEA Quality team, fostering cross‑border collaboration.
• Ensure the QMS aligns with ISO 13485, 21 CFR, MDR/IVDR, UK CA Marking and other relevant standards.
• Partner with Regulatory, Operations, R&D, Supply Chain, Legal and Commercial teams to harmonise quality objectives.
• Drive Lean, Six Sigma and data‑driven initiatives to manage non‑conformances, CAPAs, complaints and post‑market surveillance.
• Act as the primary interface with regulatory authorities, notified bodies and auditors across the region.
• 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 or MBA preferred.
• Demonstrated ability to manage large, multicultural teams.
• Strong analytical, strategic thinking and communication skills.
• Fluent in English; additional languages a plus.

Required skills

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