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 the chance to impact patient care.
- Other info: Opportunity to work in a dynamic environment with tangible impact on patient outcomes.
- Why this job: Join a growing company and enhance quality processes that truly matter.
- Qualifications: Experience in quality management within medical device manufacturing and knowledge of ISO 13485.
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.
- 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.
Quality Manager in Welwyn Garden City employer: ProTech Recruitment Ltd
Join a well-established UK medical device manufacturer located near Welwyn Garden City, where you will play a pivotal role in enhancing the Quality Management System and driving continuous improvement. With a strong focus on employee development and a collaborative work culture, this company offers competitive salaries and the chance to make a meaningful impact on patient care through high-quality medical devices. Enjoy the benefits of working in a supportive environment that values innovation and compliance, while contributing to essential healthcare solutions.
