Contract Quality Assurance Engineer

Birmingham

9 months ago

Applications closed

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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

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