Quality Manager
Permanent role based in Surrey, United Kingdom.
About the role
This Quality Manager role is responsible for building, maintaining and developing the Quality Management System, ensuring ongoing compliance with relevant medical device, regulatory and market access requirements. You will oversee quality and technical documentation, support product launches, manage change control, and help ensure the company remains compliant in its role as both legal manufacturer and distributor.
A key part of the position will be managing incident investigations, post-market surveillance data and quality tickets through the company’s systems, while providing practical support to customer care, warehouse and operations teams. You will also maintain product files, certifications and registrations, and help coordinate with external compliance advisers to keep the business and its products compliant throughout the lifecycle.
Responsibilities
- Build, maintain and improve the QMS in line with EU MDR, MHRA and wider medical device requirements, ensuring the system remains practical, current and audit-ready.
- Own and update technical and quality documentation in COGNIDOX, including process documents, product files, change control records and supporting materials.
- Manage post-market activity through Zoho ERP and service desk workflows, including incident investigation, quality tickets, PMS data gathering and non-conformance tracking.
- Support product launches and ongoing maintenance by updating IFUs, labels, packaging, shipping documentation, registrations and filing requirements.
- Work closely with internal teams, suppliers and external compliance advisers to manage risk, support product changes and maintain regulatory compliance across the product lifecycle.
Requirements
- Proven quality management experience within Medical Devices.
- Strong working knowledge of UK medical device regulations and EUDAMED.
- Hands-on QMS development and maintenance experience.
- Experience with audit, risk and incident management.
- Strong IT skills, ideally with COGNIDOX and Zoho ERP or similar systems.
Pay
£45,000 to £50,000 per year.