Role: Quality Assurance Engineer – Medical Devices Type: 6 Month Contract Pay: £40 per hour – Inside IR35 Hours: 09:00 – 17:00 Mon-Fri Location: Fully Remote with occasional visits to Birmingham site Are you a Quality Assurance Engineer contractor looking for your next contract? I’m currently representing my Medical Devices client based in Birmingham who are looking for a Quality Engineer to join them on a contract basis. Quality Engineer -

Supplier & Purchasing Oversight : Ensure supplier and purchasing processes comply with regulations; develop supporting documents, supplier controls, and quality agreements.

Labelling Compliance : Review and create procedures for product and software labelling to meet all regulatory requirements.

Regulatory Registration Support : Prepare documentation packs for global device registrations; maintain a master list of active registrations and develop related procedures.

Technical Documentation & Risk Management : Maintain regulatory files, support risk management activities, and document process risks per ISO 14971.

Quality Data & Trend Analysis : Develop systems for collecting and analysing quality data to identify trends and drive improvements.

Training Development : Create training materials on applicable regulations and standards and implement a refresher training process for key quality procedures.

Project Engineer - Essential Experience/Skills/Qualifications

Proven experience in quality assurance and regulatory affairs within the medical device sector, including creating procedures and technical documentation.

Strong analytical, problem-solving, and detail-oriented skills with the ability to manage multiple projects and priorities.

In-depth knowledge of international medical device regulations and standards (e.g., MDSAP, EU MDR 2017/745, ISO 13485, ISO 9001, ISO 14971).

Excellent regulatory writing, communication, and interpersonal collaboration skills.

Proficient in using QMS tools and electronic document management systems; experienced with MS Office, SharePoint, and MS Teams.

Highly organized, professional, and collaborative; effective in team environments and capable of independently planning and managing tasks.

If you are a Quality Assurance Engineer and are interested, please apply now with your latest CV.