Quality Manager
2 weeks ago
Quality Manager
Full-Time | UK | International Travel Required
We are supporting an online retail brand in hiring an experienced
Quality Manager
to lead their Quality Management System and ensure global regulatory compliance. This is a key hands-on role within Operations, ideal for someone who thrives in a fast-moving environment and is confident working across QMS, audits, regulatory requirements, and post-market activities.
What You'll Do
- Lead, maintain and improve the ISO 13485–compliant Quality Management System
- Oversee audit readiness (ISO 13485, MDSAP) and manage internal & external audits
- Ensure compliance with EU MDR, FDA QSR, and key product safety standards
- Manage Technical Files, Design History Files, CAPA, document control & change management
- Lead Post-Market Surveillance, complaint handling and vigilance activities
- Support clinical and regulatory teams with quality data and documentation
- Oversee supplier quality, qualification, audits and quality agreements
- Champion digital tools to enhance QMS efficiency and data integrity
- Train teams and promote a strong quality culture across the organisation
What We're Looking For
- 5–7+ years' Quality Assurance experience in the medical device industry
- Strong knowledge of ISO 13485, FDA 21 CFR Part 820, ISO 14971 and EU MDR
- Experience managing audits, CAPA, design controls and process validation
- Confident with QMS software and electronic document control tools
- Excellent communication, organisation and stakeholder management skills
Bonus Skills
- Experience with Annex XVI devices and EU Common Specifications
- MDSAP audit experience
- Exposure to international regulatory markets (e.g., Health Canada, TGA)
- SME or startup experience
For more information, please apply online or contact the Fella & Jones team
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