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    • This permanent role will see you play a key part in assessing and improving Quality Management Systems for software-based medical devices.
    • Working knowledge of ISO 13485 (medical device quality management) and IEC 62304 (medical device software lifecycle).
    • Potential to influence quality standards and testing approaches.
    • Professional development opportunities within a technical quality environment.
    • Strong understanding of ISO 9001 quality management principles.
    • Exposure to best practices in quality assurance and continuous improvement.
    • Familiarity with ISO 9001 standards and quality management principles.
    • Scope to develop expertise in automated testing and quality assurance practices.
    • Additional certifications in quality management or medical device compliance.
    • Experience with Class III medical device validation, testing or quality assurance.
    • Experience in system validation, testing or quality assurance within a medical device or regulated environment.
    • Strong analytical and problem-solving skills.
    • Autolus has a pipeline of product candidates in development for the treatment of haematological malignancies, solid tumours, and autoimmune diseases.
    • Identifying, managing and communicating defects and quality risks through Jira.
    • Collaborating with engineers, Product Owners, UX/UI Designers and Business…
    • 2–5 years' experience in regulatory affairs, quality assurance or compliance within medical device or pharmaceutical environments.
    • Domain: Class III medical device · Validation and quality assurance.
    • Experience with system validation, testing or quality assurance in a medical device or…
    • Domain: Class III medical device · ISO 13485 · IEC 62304.
    • Working knowledge of ISO 13485, IEC 62304 and Class III medical device validation.
    • System Validation Engineer opportunities in medical device development typically sit within quality-focused teams delivering Class III medical devices under ISO…
    • An interest in medical devices or regulated industries.
    • Contribute ideas to improve build quality, efficiency and test processes.
    • Time on the Production Floor.
    • Background in quality, engineering or with manufacturing experience.
    • Private medical insurance with BUPA for you and your family.

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Job Post Details

Medical Device Auditor
London
£75,000 a year
Permanent

Job details

£75,000 a year
Cycle to work scheme
Permanent
London

Full job description

Medical Device Auditor - London / Remote We are partnering with our client to help them appoint a Medical Device Auditor. This permanent role will see you play a key part in assessing and improving Quality Management Systems for software-based medical devices. Key Skills & Experience
  • Medical Device Industry Experience (4+ years)
  • ISO 13485 QMS Auditing/Management
  • EU MDR / UK MDR for QMS
  • Software & SaMD Expertise desirable
Offered:
  • Up to £90,000 per annum
  • Share options
  • EV and cycle to work scheme
Interested? If you are looking to apply your quality expertise in a high-impact role within our client's team, please apply to this with your CV and we'll be in touch! To find out more about Computer Futures please visit www.computerfutures.com Computer Futures, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy | Registered office | 8 Bishopsgate, London, EC2N 4BQ, United Kingdom | Partnership Number | OC387148 England and Wales
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