Contract Quality Assurance Engineer Position Available In Jefferson, Alabama
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Job Description
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
