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