Quality Assurance Engineer

Quality Assurance Engineer

Posted 1 week ago by Owen Daniels

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£40 Per hour
Inside
Remote
Birmingham, England, United Kingdom
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Data Analysis Document Management Electronic Document Management Electronic Documents Management Market Trend Microsoft Office Microsoft SharePoint Risk Management Technical Documentation Trend Analysis

Summary: The Quality Assurance Engineer role is a 6-month contract position focused on ensuring compliance with regulations in the medical devices sector. The position involves supplier oversight, labelling compliance, regulatory registration support, and quality data analysis. The role is fully remote with occasional visits to the Birmingham site, requiring strong analytical and regulatory skills. Candidates must have proven experience in quality assurance within the medical device industry.

Key Responsibilities:

  • Ensure supplier and purchasing processes comply with regulations; develop supporting documents, supplier controls, and quality agreements.
  • Review and create procedures for product and software labelling to meet all regulatory requirements.
  • Prepare documentation packs for global device registrations; maintain a master list of active registrations and develop related procedures.
  • Maintain regulatory files, support risk management activities, and document process risks per ISO 14971.
  • Develop systems for collecting and analysing quality data to identify trends and drive improvements.
  • Create training materials on applicable regulations and standards and implement a refresher training process for key quality procedures.

Key Skills:

  • 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.

Salary (Rate): £40 hourly

City: Birmingham

Country: United Kingdom

Working Arrangements: remote

IR35 Status: inside IR35

Seniority Level: Mid-Level

Industry: IT

Detailed Description From Employer:

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 Assurance 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.

Quality Assurance 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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