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

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