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 - Job Description
* 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.