Quality Engineer
5 days ago
City of London
Quality / Manufacturing Engineer (Medical Devices) 📍 London (fully on-site) | Commutable within ~1 hour of South Kensington We’re supporting a growing medical device organisation seeking an experienced Quality / Manufacturing Engineer to join their team. This role will play a key part in ensuring product quality, regulatory compliance, and manufacturing excellence across sterile, high-risk devices. Key Responsibilities • Support manufacturing and quality activities for Class IIb / III medical devices, • Ensure compliance with ISO 13485 and 21 CFR Part 820, • Work closely with legal manufacturers and/or contract manufacturing partners, • Collaborate with production teams and external suppliers on quality and process improvements, • Lead and support root cause investigations for manufacturing-related issues, • Manage CAPAs, non-conformances, and complaints, • Support and maintain change control processes, • Review and update procedures and work instructions, • Contribute to internal and external audit activities Essential Experience • Strong background in medical devices, • Working knowledge of ISO 13485 and 21 CFR 820, • Experience working with legal manufacturers or subcontract manufacturers, • Understanding of QC processes and GD&T on engineering drawings, • Knowledge of process risk management and process validation, • Hands-on experience with CAPA, non-conformances, and complaint handling, • Experience liaising with production teams and/or external suppliers, • Experience with change control systems, • Internal and external audit experience Desirable Skills • Validation protocol authoring, • Experience setting up new production lines or processes, • Exposure to additive manufacturing, • Experience authoring procedures, • Engineering background, • Lead auditor training, • Previous experience in a start-up environment Additional Requirements • Must be within a reasonable commuting distance (~1 hour) of South Kensington