Quality Manager

Quality Manager - Medical Devices

Salary: 60,000 - 70,000
Location: Nr Welwyn Garden City
Medical Device Manufacturing ISO 13485 Class IIa & IIb Devices

We are working exclusively with a well established UK medical device manufacturer supplying products to the NHS and healthcare sector. They are looking to appoint an experienced quality professional to take ownership of their Quality Management System and help drive continuous improvement across the business.

This is a hands-on role within a manufacturing environment, supporting a portfolio of medical devices (predominantly Class IIa, with some Class IIb product) manufactured on-site under ISO 13485.

Key Responsibilities

• Maintain and improve the ISO 13485 Quality Management System.
• Manage non-conformances, CAPAs and returned product investigations (RMA).
• Drive continuous improvement of quality processes and procedures.
• Support supplier quality activities across a broad supplier network.
• Lead and support internal and external audits, including interactions with BSI.
• Assist with technical documentation and technical file maintenance where possible.
• Ensure ongoing compliance with UK and European medical device regulations.

About You

• Previous experience in a Quality Manager, Senior Quality Engineer or similar position within a medical device manufacturing environment.
• Strong working knowledge of ISO 13485.
• Experience managing non-conformances, CAPAs and quality investigations.
• Comfortable working in a small to medium sized business where you can make a tangible impact.
• Experience writing or maintaining technical files would be highly advantageous.
• Regulatory experience would be useful, although this role is primarily quality focused.

This is an excellent opportunity to join a successful and growing manufacturer whose products make a genuine difference to patient care. The products themselves are relatively straightforward, making this a great role for someone who enjoys improving systems, ensuring compliance and driving quality excellence across a business.

For a confidential discussion, please contact us.