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 at contact@fellaandjones.com