Quality Manager

Role Overview

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.

About You

To be successful as the new Quality Manager, you will have proven QMS implementation experience within the Medical Device sector. You’ll have strong knowledge of UK medical device regulations, excellent communication skills and the ability to work across teams will be essential. Confidence with technical documentation, incident management and business systems will also be important.

Role 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.

Key Requirements / What We Look For

• 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.