Medical Device Quality Engineer Jobs

• Gloucester
• On-site
• £45,000 – £50,000 pa
• Mid-level
• Permanent

Support and maintain the effectiveness of a medical device manufacturer's QMS in line with ISO 13485, MDR and FDA requirements. Day-to-day work covers CAPA effectiveness, quality data and trend analysis, non-conformances, change control and complaint investigation, plus writing and updating procedures and work instructions.

ISO 13485 · FDA Quality System

• Dorking
• On-site
• Mid-level
• Permanent

Resolve customer-raised product quality issues, lead root cause analysis using 8D, 5 Whys and Fishbone, and drive permanent corrective actions within a Quality Management System. Support new product introductions, review engineering changes, and track KPIs like Defects Per Unit while working cross-functionally with Production, Engineering and Supply Chain in a manufacturing environment.

Excel · Pivot Tables · Pareto Charts

• Lancashire
• On-site
• Mid-level
• Contract

Maintains and improves a medical device Quality Management System in line with ISO 13485 and FDA QSR, leading non-conformance, deviation, complaint and CAPA investigations with root cause analysis. Supports internal, supplier and regulatory audits, risk management under ISO 14971, validation and design transfer, working with Manufacturing, R&D, Regulatory Affairs and Supply Chain.

• Fareham
• Hybrid
• Mid-level
• Permanent

Maintains and improves a medical device Quality Management System, planning and reporting internal audits and leading external audit readiness with evidence packs and follow-up actions. Supports ISO 13485 compliance, ISO 14971 risk activities, CAPA and document control, and leads quality improvement projects in a regulated scale-up environment.

• Houghton le Spring
• On-site
• Temporary

Support quality assurance, product compliance and regulatory activities in a medical device manufacturing environment. Maintain quality control systems, prepare technical documentation, conduct testing and inspections, investigate non-conformances using CAPA, analyse quality data and support internal and external audits, working closely with the QA Manager and production teams.

ISO 13485 · EU MDR

• Oxford
• On-site
• Mid-level
• Permanent

Assures software quality across the full lifecycle for medical devices up to IEC 62304 safety class C, covering design controls, requirements, verification and validation, and release management. A central duty is software risk management, developing and maintaining SFMEAs, hazard analyses and cybersecurity risk assessments aligned with ISO 14971. Works with R&D, Engineering, Post-Market Operations, Regulatory Affairs and Cybersecurity to support EU MDR and FDA compliance.

IEC 62304 · ISO 14971 · ISO 13485 +5

• London
• On-site
• £76,800 – £115,200 pa
• Senior

Supports software quality across the full product development lifecycle in Medtronic's surgical operating unit, from requirements and design through verification, validation, release and post-market support. Involves risk management (SFMEA, hazard analysis), design reviews, traceability documentation, CAPA and audit readiness, working closely with software, systems, regulatory and quality teams.

ISO 13485 · ISO 14971 · IEC 62304 +3

• Houghton le Spring
• £37,000 – £40,000 pa
• Contract

Support quality and regulatory requirements across design, manufacture and testing of medical devices. Maintain quality procedures, analyse performance data, manage CAPA activities, and assist with inspections, audits and clean-room production standards. A 12-14 month maternity cover contract within a specialist manufacturing environment.