Product Quality Engineer - Medical Devices

CT19; Kidlington; On-site; GBP 50,000 - 80,000; Full time

Job summary

A growing medical imaging company in Kidlington is seeking a Product Quality Engineer to oversee quality assurance and regulatory compliance. The ideal candidate will have a degree in Science or Engineering and experience with ISO 13485 and FDA regulations. Responsibilities include managing quality control activities, supporting documentation, and collaborating with various teams to ensure product quality and compliance. This role offers an exciting opportunity to contribute to innovative 3D imaging technology.

Qualifications

• Experience in quality engineering activities for medical devices.
• Strong understanding of ISO 13485 and FDA regulations.
• Ability to manage NCRs, CAPAs, and continuous improvement initiatives.
• Familiarity with cybersecurity standards for medical devices.
• Lean/Six Sigma methodologies and tools.
• Strong planning and communication skills.

Responsibilities

• Lead quality assurance and quality control activities.
• Oversee risk management planning and reporting.
• Collaborate with teams to maintain product quality.
• 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.

Skills

Degree in Science or Engineering

Quality Management System qualification

Knowledge of product development and quality systems

Familiarity with ISO 13485 and FDA QSR

Skilled in Lean/Six Sigma methods

Excellent planning and communication skills

Lean Six Sigma

Minitab

DOE

SPC

Planning

Problem solving

Communication

Education

Degree in Science or Engineering or equivalent experience

Tools

Minitab

DOE

SPC

Job description

Overview

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.