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Software Quality Engineer

Job in Greater London, London, Greater London, W1B, England, UK
Listing for: LennTech Search
Full Time position
Listed on 2026-01-22
Job specializations:
  • Software Development
    Software Engineer, Software Testing
Job Description & How to Apply Below
Location: Greater London

Lenn Tech Search are working with an exciting biotechnology company pioneering new technologies to improve patient health.

Main Duties

  • Subject matter expert in providing software quality guidance and support to software development teams.
  • Provide software quality guidance for projects with focus on analytical software (bioinformatics pipeline and AI software ) to ensure compliance with company SDLC and QMS.
  • Participate in Verification and Validation approach, Risk Management strategies.
  • Support and provide guidance for regulatory submissions such as PMA, IDE, and pre-sub.
  • Ensure quality and completeness of design history files for software
  • Ensure SDLC processes meet quality and regulatory requirements and identify areas and opportunities to improve quality system processes.

Education and Experience

  • Knowledge of product development, and specifically software development (SDLC) processes, Design Controls.
  • Minimum of 3+ years’ experience in software quality engineering or related role in a medical device / IVD company environment.
  • Working experience with relevant industry standards (FDA 21 CFR 820, ISO 13485, ISO 14971, IEC 62304)
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