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? Opportunity to work in a true Medical Devices environment with full exposure to ISO 13485 systems Small, collaborative team where your input directly shapes quality processes and compliance standards Hands-on role with visibility across manufacturing, quality systems, and regulatory activity 23 days holiday plus bank holidays HealthShield Classic health cash plan (post-probation) supporting dental, optical and wellbeing costs Stable working environment with a strong focus on quality and continuous improvement Occasional ad hoc flexibility to work from home where appropriate What’s next? It’s easy! Click “APPLY” now! We can’t wait to hear from you! Your data will be handled in line with GDPR.