At a Glance
- Tasks: Lead quality management for medical devices and drive continuous improvement.
- Company: Established UK medical device manufacturer making a difference in healthcare.
- Benefits: Competitive salary, hands-on role, and opportunity to impact patient care.
- Other info: Make a tangible impact in a supportive, dynamic environment.
- Why this job: Join a growing company and enhance quality processes in a meaningful industry.
- Qualifications: Experience in quality management within medical device manufacturing and knowledge of ISO 13485.
The predicted salary is between 60000 - 70000 £ per year.
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.
Quality Manager employer: ProTech Recruitment
Join a well-established UK medical device manufacturer located near Welwyn Garden City, where your expertise as a Quality Manager will directly contribute to enhancing patient care. With a strong focus on continuous improvement and a collaborative work culture, this company offers excellent growth opportunities in a hands-on role that allows you to make a tangible impact within a supportive environment. Enjoy the benefits of working with a dedicated team committed to quality excellence and compliance in the healthcare sector.
