Job Title

Role: Quality Assurance Engineer Medical DevicesMake sure to apply quickly in order to maximise your chances of being considered for an interview Read the complete job description below.Type: 6 Month ContractPay: 40 per hour Inside IR35Hours: 09:00 17:00 Mon-FriLocation: Fully Remote with occasional visits to Birmingham siteAre you a Quality Assurance Engineer contractor looking for your next contract? Im currently representing my Medical Devices client based in Birmingham who are looking for a Quality Engineer to join them on a contract basis. Quality Assurance Engineer - Job DescriptionSupplier & 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.Quality Assurance Engineer - Essential Experience/Skills/QualificationsProven 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.