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    Software Quality Engineer

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      Software Quality Engineer

      Location: Fully Remote

      Salary: £55-70 per hour

      Contract Type: Hourly Rate (6 Months)

      LennTech 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)
      • Occasional travel may be required