Director, Quality Assurance EMEA

About the role

As the Quality Management Representative for the EMEA region, you will lead Hologic’s Quality Assurance function, ensuring compliance with global and regional regulations while driving continuous improvement across international markets. You will shape the quality culture, mentor a diverse team, and act as the primary interface with regulatory authorities.

Key responsibilities

• Lead and develop the EMEA Quality team, fostering high performance and cross‑border collaboration.
• Ensure the Quality Management System complies with ISO 13485, 21 CFR, MDR/IVDR, UK CA Marking and other relevant regulations.
• Partner with Regulatory, Operations, R&D, Supply Chain, Legal and Commercial functions to align quality objectives.
• Drive Lean, Six Sigma and data‑driven initiatives to manage non‑conformances, CAPAs, complaints and post‑market surveillance.
• Champion a customer‑centric mindset and embed it in all quality activities.
• Serve as the primary contact for regulatory authorities, notified bodies and auditors throughout 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 with deep knowledge of EMEA regulations.
• Bachelor’s degree in engineering or related field; Master’s (MBA, Quality Management, Engineering) preferred.
• Demonstrated success managing large, multicultural teams.
• Strong analytical, strategic and communication skills.
• Fluency in English; additional languages a plus.
• Willingness to travel up to 15 % across the EMEA region.

Required skills

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