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. You will act as the Quality Management Representative, shaping a customer‑focused culture and supporting the expansion of Hologic’s international quality framework.

Key responsibilities

• Lead, mentor and develop the EMEA Quality team, fostering high performance and cross‑border collaboration.
• Ensure the QMS aligns 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 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 primary contact for regulatory authorities, notified bodies and auditors throughout EMEA.
• Identify and mitigate quality risks, staying ahead of regulatory changes and industry best practices.
• Provide annual GMP and audit‑readiness training.

Required profile

• Proven expertise in medical‑device quality management with deep knowledge of EMEA regulations.
• Bachelor’s degree in engineering or related field (Master’s/MBA highly preferred).
• Demonstrated success managing large, diverse, multi‑country teams.
• Strong analytical, strategic thinking and decision‑making abilities.
• Excellent communication and influencing skills at all organisational levels.
• Collaborative mindset in a global, matrixed environment.
• Fluency in English; additional languages are 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
• CAPA management
• Post‑market surveillance

What we offer

• Opportunity to impact millions of lives by ensuring the highest quality standards in healthcare.
• Leadership role within a global medical‑device company.