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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