Quality Manager - Technology Wellness Brand
Posted 2 weeks ago by Fella and Jones
£90,000 Per year
Undetermined
Hybrid
London Area, United Kingdom
Summary: The Quality Manager role at a fast-growing international wellness and health-tech business involves building and enhancing a Quality Management System for medical devices. This position is crucial for ensuring regulatory compliance, audit readiness, and operational excellence in a science-driven product environment. The role requires hands-on leadership in quality management practices and cross-functional collaboration. Candidates with experience in medical devices and a strong background in ISO standards are particularly sought after.
Key Responsibilities:
- Leading ISO 13485:2016 compliance
- Driving QMS development and continuous improvement
- Managing internal audits, CAPA, change control and supplier quality
- Supporting FDA and international regulatory compliance
- Leading preparation for MDSAP audits across multiple jurisdictions
- Overseeing risk management, post-market surveillance and complaints handling
- Partnering cross-functionally with R&D, supply chain, operations and regulatory teams
Key Skills:
- Strong ISO 13485 experience
- FDA / 21 CFR Part 820 knowledge
- Exposure to MDSAP and ISO 14971
- Experience improving or building QMS frameworks
- A practical, hands-on approach within fast-paced businesses
Salary (Rate): £90,000 yearly
City: London
Country: United Kingdom
Working Arrangements: hybrid
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
Quality Manager | Medical Devices | London Contract or Permanent considered £75,000 - £90,000
We are partnering with a fast-growing international wellness and health-tech business seeking a hands-on Quality Manager to build and elevate a best-in-class Quality Management System across its medical device portfolio. This role will play a critical part in ensuring audit readiness, regulatory compliance, and operational excellence across a highly innovative and science-led product environment.
Key responsibilities include:
- Leading ISO 13485:2016 compliance
- Driving QMS development and continuous improvement
- Managing internal audits, CAPA, change control and supplier quality
- Supporting FDA and international regulatory compliance
- Leading preparation for MDSAP audits across multiple jurisdictions
- Overseeing risk management, post-market surveillance and complaints handling
- Partnering cross-functionally with R&D, supply chain, operations and regulatory teams
We are particularly interested in candidates with experience in:
- Medical Devices
- MedTech
- Regulated Consumer Health
- Pharmaceutical / Life Sciences environments
Ideal candidates will bring:
- Strong ISO 13485 experience
- FDA / 21 CFR Part 820 knowledge
- Exposure to MDSAP and ISO 14971
- Experience improving or building QMS frameworks
- A practical, hands-on approach within fast-paced businesses
London based | Hybrid working. Please reach out directly for a confidential discussion or to recommend someone suitable.