Quality Engineer – Medical Devices

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

The full job description covers all associated skills, previous experience, and any qualifications that applicants are expected to have.
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 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?
Maintaining and continuously improving 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, including technical documentation

Managing investigations into non-conformances, complaints and quality issues

Conducting 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 opportunities for improvement

Supporting supplier approval, monitoring and ongoing quality performance

Assisting with validation activities and production quality verification

Working closely with manufacturing and cross-functional teams to maintain product quality

Supporting the QA/RA Director with departmental workload and compliance priorities

Promoting a proactive, continuous improvement-led quality culture across the business

Are you the right person for the job?
Proven experience within the medical devices industry (essential)

Around 5 years' experience in a quality-related role, although this is flexible for the right candidate

Strong working knowledge of ISO 13485 and Quality Management Systems

Practical experience with QMS processes, including CAPA, document control, change control, deviations and non-conformance reports (NCRs)

Experience supporting or leading internal and external audits xwzovoh

Understanding of regulatory requirements, including UK MDR, EU MDR 2017/745, CE marking and UKCA

Experience conducting root cause analysis and quality investigations

Degree in a scientific, engineering or related discipline, or equivalent industry experience

Must be UK-based with existing right to work in the UK (sponsorship is not preferred)

What's in it for you?
Salary of up to £45,000, depending on experience

23 days' annual leave plus bank holidays

HealthShield Classic health cash plan following probation, supporting dental, optical and wellbeing costs

Opportunity to work in a specialist medical devices environment with exposure to ISO 13485 and regulatory compliance

Small, collaborative team where your input directly contributes to quality processes and compliance standards

Hands-on role with visibility across manufacturing, quality systems and regulatory activities

Stable working environment with a strong focus on quality and continuous improvement

Occasional flexibility to work from home where appropriate