Quality Engineer - Medical Devices

Cameron Clarke Associates t/a talent-finder; Leeds; On-site; GBP 41,000 - 50,000; Full time

Job summary

Cameron Clarke Associates t/a talent-finder in Leeds seeks a hands-on Quality Engineer for a medical devices environment. You will own the QMS, ensure ISO 13485 alignment, and support UKCA/CE/MDR requirements while collaborating with manufacturing and cross-functional teams to maintain high product quality.

The role offers visibility, real ownership, and scope to drive continuous improvement in a small but growing medical devices company. Prior medical devices experience is essential.

Qualifications

• Experience in medical devices quality systems and ISO 13485.
• Strong knowledge of QMS processes: CAPA, document control, change control, deviations, NCRs.
• Experience supporting or leading internal/external audits.
• Familiar with MDR/UK MDR and UKCA requirements.
• Degree in science/engineering or related discipline.

Responsibilities

• Own and maintain the QMS in line with ISO 13485.
• Ensure quality processes and documentation remain compliant and effective.
• Support UKCA, CE and MDR regulatory compliance activities and technical documentation.
• Lead and support investigations into non-conformances, complaints and quality issues.
• Carry out root cause analysis and implement CAPA.
• Support internal and external audits, including preparation and follow-up actions.
• Monitor quality data and trends to identify risks and drive improvement.
• Support supplier approval and ongoing quality performance.
• Assist with validation activities and production quality verification where required.
• Work closely with manufacturing and cross-functional teams to ensure product quality.
• Support the QA/RA Director with departmental workload and priorities.
• Contribute to a proactive, improvement-led quality culture.

Skills

Medical Devices

ISO 13485

CAPA

Document control

Change control

Deviations

NCRs

Audits

MDR

UK MDR

UKCA

Root cause analysis

Quality investigations

Right to work

Education

Bachelor's degree in science/engineering

Job description

Quality Engineer - Medical Devices | Leeds | Full Time | On-site (with occasional flexibility) | Up to £45,000 (DOE)

This is a hands-on Quality Engineer role within a specialist UK medical device manufacturer, where quality, compliance, and patient safety are central to everything the business does. You'll be joining a close-knit Quality & Regulatory team within a small but growing organisation of around 40 employees, working alongside experienced quality professionals and with support from a QA/RA leadership structure. The environment is collaborative and highly involved, with strong exposure to both manufacturing operations and quality system ownership.

The role sits at the heart of maintaining and continuously improving a well-established Quality Management System (QMS), with a strong focus on ISO 13485 compliance and ongoing adherence to UKCA and CE marking requirements. You'll take ownership of day-to-day quality activities including document control, non-conformance management, CAPA, and audit preparation, while also supporting both internal and external audits. Alongside this, you'll contribute to continuous improvement initiatives and help strengthen quality processes across the business.

This position is best suited to someone with direct medical device industry experience who is confident working within a regulated manufacturing environment. Given the size of the organisation, this is a highly visible role where you'll be trusted with real ownership and the opportunity to make a tangible impact. The business is also open to considering strong mid-level candidates who are looking to further develop within a supportive medical devices environment.

What will your role look like?

• Owning and maintaining the Quality Management System (QMS) in line with ISO 13485
• Ensuring quality processes, procedures and documentation remain compliant and effective
• Supporting UKCA, CE and MDR regulatory compliance activities and technical documentation
• Leading and supporting investigations into non-conformances, complaints and quality issues
• Carrying out root cause analysis and implementing effective corrective and preventive actions (CAPA)
• Supporting internal and external audits, including preparation, participation and follow-up actions
• Monitoring quality data and trends to identify risks and drive continuous improvement
• Supporting supplier approval, monitoring and ongoing quality performance
• Assisting with validation activities and production quality verification where required
• Working closely with manufacturing and cross-functional teams to ensure product quality is maintained
• Supporting the QA/RA Director with departmental workload and compliance priorities
• Contributing to a proactive, improvement-led quality culture across the business

Are you the right person for the job?

• Proven experience within the Medical Devices industry (essential)
• Strong working knowledge of ISO 13485 and Quality Management Systems
• Around 5 years' experience in a quality-related role (flexible for the right candidate)
• Confident working with QMS processes such as CAPA, document control, change control, deviations and NCRs
• Experience supporting or leading internal and external audits
• Exposure to MDR 2017/745 / UK MDR requirements
• Understanding of regulatory frameworks including UK MDR, EU MDR/CE and UKCA
• Experience in root cause analysis and quality investigations
• Degree in a scientific, engineering or related discipline (or equivalent experience)
• UK-based with existing right to work (sponsorship not preferred)

What's in it for you?

• Oppor