Remote Quality Assurance Engineer

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.

• 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.