Product Quality Engineer – Medical Devices
Location: Kidlington
Salary: Highly Negotiable, Dependent on Experience
An exciting opportunity to join a growing medical imaging company developing cutting-edge 3D imaging technology. With commercialisation underway in the UK and US, we are expanding our manufacturing capability and seeking a Product Quality Engineer to strengthen the Quality & Regulatory Affairs team.
Role Overview
The Product Quality Engineer will plan, coordinate, and manage quality assurance and quality control activities across product development, manufacturing, and post-market. This includes developing DHF deliverables, supporting verification/validation, managing non-conformances and CAPAs, and providing compliance guidance to colleagues. The role plays a key part in ensuring adherence to ISO 13485, FDA 21 CFR 820 (transitioning to QMSR), and CE/510k requirements.
Key Responsibilities
* Lead and support quality engineering activities for medical, veterinary, and non-destructive testing systems.
* Contribute to design and manufacturing documentation, ensuring products can be effectively manufactured and tested.
* Oversee risk management planning, assessment, and reporting for new and modified products.
* Support design transfer, supplier qualification, and quality test method validation.
* Generate and maintain quality documentation, including SOPs, work instructions, and inspection procedures.
* Manage NCRs, CAPAs, and continuous improvement initiatives.
* Collaborate with R&D, suppliers, and manufacturing teams to embed quality throughout the lifecycle.
* Provide training and guidance on regulatory compliance and quality standards.
Qualifications & Skills
* Degree in Science or Engineering, or equivalent experience.
* Recognised Quality Management System qualification (e.g., ISO auditor) or similar experience.
* Strong knowledge of product development, manufacturing, and quality systems in regulated industries, ideally medical devices.
* Familiarity with standards such as ISO 13485, FDA QSR, risk management (FMEA), and medical device cybersecurity.
* Skilled in Lean/Six Sigma methods and tools such as Minitab, DOE, and SPC.
* Excellent planning, problem-solving, and communication skills, with the ability to work independently and collaboratively.
This is a great opportunity to join an innovative scale-up and directly contribute to the delivery of high-quality, safe, and effective products to market.