Quality Assurance Director

Director of Quality Compliance, EMEA (Medical Devices)

I’m currently partnering with a leading international Medical Device organisation to appoint a Head of Quality Compliance, EMEA. A senior leadership role with full ownership of quality strategy, compliance, and QMS performance across the region.

This is a high-impact position where you’ll lead QMS, Supplier Quality, and Divisional QA teams, ensuring compliance with EU MDR 2017/745, ISO 13485, and global standards, while driving continuous improvement and operational excellence across multiple sites.

Key focus areas:
• Leadership of regional Quality & Compliance strategy across EMEA
• Oversight of QMS (CAPA, audits, change control, management review)
• Supplier quality and finished goods compliance
• Design controls, risk management (ISO 14971), and product lifecycle quality
• Cross-functional collaboration with RA, R&D, Operations, and global stakeholders
• Leading audits (Notified Bodies, authorities, customers) and regulatory readiness
• Driving harmonisation and simplification of QMS across sites

What we’re looking for:
• 10+ years in Medical Device Quality (Class I/II preferred)
• Strong expertise in EU MDR, ISO 13485, and end-to-end QMS
• Proven leadership experience across multiple teams and locations
• Track record in building quality culture and influencing senior stakeholders
• Strategic mindset with hands-on execution capability
• Expertise with product development activities, including DHF, design controls..

Why consider this role?
You’ll be joining a growing, globally connected business where quality is at the core of innovation and market expansion, offering real scope to shape strategy, lead transformation, and make a lasting impact.

If this sounds like you (or someone in your network) feel free to reach out for a confidential discussion.

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