Job Title: Quality Engineer
Location: South Kensington, London (Office-based with hybrid flexibility)
Salary: £50,000
Employment Type: Full-time, Permanent
Company Overview
We are a London-based medical device organisation specialising in the design, development, and manufacture of innovative, high-risk medical technologies. Operating within a regulated environment, we focus on delivering high-quality, sterile products that meet stringent global standards, supporting improved patient outcomes worldwide.
The Role
We are seeking a Quality Engineer to join our growing team in South Kensington. This is a hands-on role within a dynamic environment, supporting both manufacturing and quality system activities. You will play a key role in ensuring compliance with regulatory standards while driving continuous improvement across processes, products, and the wider Quality Management System.
This position offers the opportunity to work closely with cross-functional teams, including production and external suppliers, in a fast-paced and collaborative setting.
Key Responsibilities
* Support and maintain the Quality Management System in line with ISO 13485 and 21 CFR Part 820
* Manage and support CAPA, non-conformances, and customer complaints, including root cause investigations related to manufacturing issues
* Work closely with production teams and external suppliers to resolve quality issues and drive improvements
* Participate in and support both internal and external audits (front room and back room activities)
* Lead and support change control activities
* Review and update procedures, work instructions, and quality documentation
* Contribute to process validation and process risk management activities
* Interpret engineering drawings and apply knowledge of GD&T within quality processes
* Support supplier quality activities and ongoing performance monitoring
Essential Requirements
* Experience within the medical device industry, specifically Class IIb and/or Class III devices
* Strong knowledge of ISO 13485 and 21 CFR Part 820
* Experience working with sterile products
* Background working for a legal manufacturer or a subcontract manufacturer supplying to a legal manufacturer
* Solid understanding of quality control principles and GD&T on engineering drawings
* Experience in process risk management and process validation
* Proven track record managing CAPA, non-conformances, and complaints
* Strong root cause investigation skills, particularly for manufacturing-related issues
* Experience liaising with production teams and/or external suppliers
* Experience managing change control processes
* Experience reviewing and updating quality documentation
* Experience supporting external audits (front and back office) and conducting internal audits
Desirable Skills & Experience
* Experience authoring validation protocols
* Experience setting up new production lines or manufacturing processes
* Exposure to additive manufacturing technologies
* Experience authoring procedures and quality documentation
* Engineering background
* Lead auditor training or certification
* Previous experience working in a start-up or scale-up environment
What We Offer
* Competitive salary of up to £50,000
* Opportunity to work on cutting-edge medical technologies
* Collaborative and innovative working environment
* Career development within a growing organisation
* Flexible hybrid working options