Manufacturing Engineer - Quality Engineering

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