Quality Manager - Technology Wellness Brand in London

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