About this role
Senior Manager Quality Assurance Senior Manager of Quality Compliance, EMEA (Medical Devices) I'm currently partnering with a leading international Medical Device organisation to appoint a Senior Manager of Quality Compliance, EMEA. A senior leadership role with full ownership of quality strategy, compliance, and QMS performance across the region.
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..