Quality Engineer

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

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