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Quality Engineer
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Job Title: Quality Engineer (Medical Devices)
Company: Leading Medical Device / Healthcare Manufacturer (Confidential)
Location: West London, UK (On-site / Office-based)
Employment Type: Full-time, Permanent
Compensation: £50,000 – £55,000 per annum + Performance Bonus & Comprehensive Benefits
Role Overview
A fast-growing, innovation-driven medical device manufacturer specialising in advanced wound care, skin integrity, and infection prevention is seeking a proactive Quality Engineer.
Based out of their West London headquarters, this individual will take ownership of maintaining and strengthening the Quality Management System (QMS) to ensure uncompromising adherence to ISO 13485, applicable Medical Device Regulations (UK MDR / EU MDR), and customer specifications.
Key Responsibilities
- QMS Compliance & Administration: Maintain and enhance core QMS processes, including Document Control, Change Control, Risk Management (ISO 14971), and CAPA lifecycle tracking.
- Audits & Post-Market Surveillance: Plan, coordinate, and execute internal audits; support vigilance reporting and post-market surveillance activities to maintain regulatory compliance.
- Supplier & Subcontractor Quality: Manage external partner oversight by reviewing batch manufacturing records, Certificates of Analysis/Conformity (CoA/CoC), and sterilisation validation data.
- Batch & Product Release: Lead batch assessment and product release protocols, ensuring non-conforming products are isolated and thoroughly investigated.
- Quality Data & Trend Analysis: Collect, evaluate, and present key quality metrics to drive root-cause investigations, remediation plans, and strategic process improvements.
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Candidate Profile & Requirements
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- Regulatory & Standards Expertise: Solid working knowledge of medical device Quality Management Systems (ISO 13485 required; familiarity with ISO 14971, UK MDR, and EU MDR highly desirable).
- Supplier Quality Operations: Direct experience handling batch documentation, supplier qualifications, and third-party sterilisation data review.
- CAPA & Root Cause Analysis: Proven capability leading investigations (e.g., 5 Whys, Fishbone) and closing out preventive/corrective actions.
- Interpersonal & Analytical Skills: Strong data literacy, high attention to detail, and the ability to collaborate cross-functionally across R&D, supply chain, and regulatory affairs.
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