Senior/Staff Quality Engineer (Software Design Controls) at Tempus
Passionate about precision medicine and advancing the healthcare industry?
Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
We are looking for a Senior/Staff Quality Engineer (Software Design Controls) who will be involved in the implementation, support and continuous improvement of software quality management system (QMS) and software development life cycle (SDLC) framework, in accordance with FDA’s Quality System Regulation (QSR), ISO 13485 and other applicable regulatory requirements, as well as best practices in the software industry. This position will report to the VP of Quality Assurance.
- Primary point of contact for all Tempus’ software QMS and SDLC activities.
- Implement software QMS and SDLC processes in compliance with applicable regulations and best practices in the software industry, including the utilization of SDLC tools (e.g. Atlassian) in the semi-automation of design controls and DHF generation.
- Apply innovative, scalable and risk-based approaches to meeting compliance for novel technologies in a fast-paced, multi-project environment.
- Provide training and mentoring to the software, bioinformatics, data science and IT teams.
- Ensure software compliance/design controls, as applied to medical device/IVD software, and Software as a Medical Device (SaMD).
- Maintain knowledge of the evolving regulatory landscape for Digital Health, Artificial Intelligence and Machine Learning technologies, and incorporate best practices in Tempus’ SDLC processes and QMS.
- Ensure required documentation and deliverables (e.g. DHF) are generated and maintained throughout SDLC, including but not limited to SRS, SAD, SDS, V&V, trace-ability, risk management/FMEA and cyber-security.
- Support software development teams in the creation or remediation of Design History Files (DHFs).
- Lead risk management and cyber-security related activities and documentation.
- Assist with Computer System Validation including 21 CFR Part 11.
- Support compliance to various QMS policies, procedures and activities including but not limited to: CAPAs, internal and external audits, management reviews, document and change control, training, quality metrics.
- Performs other related duties and responsibilities as assigned.
- BA/B.S. or higher preferred in Computer Science, Software Engineering, Informatics, Biomedical, or relevant engineering disciplines.
- 5+ years in a software quality (design assurance/controls) role in the medical device/IVD (or FDA regulated) industry.
- Experience and working knowledge of applicable regulations and standards: FDA QSR (21CFR Part 820), ISO 13485, IEC 62304, ISO 14971, 21CFR Part 11.
- Expertise in SDLC best practices, and experience with state-of-the-art SDLC tools.
- Experience working with Agile/Scrum/iterative software development methodology.
- Working knowledge of the application of regulatory requirements for medical device software, SaMD and digital health technologies using a scalable approach to the SDLC practices and the QMS.
- Familiarity with (or interest in developing a knowledge of) Laboratory Developed Tests (LDTs), Companion Diagnostics (CDx), genetic (Next-Generation Sequencing - NGS) based tests; CLIA/CAP and Pharma/GCP regulations.
- Excellent organizational, interpersonal and verbal and written communication skills
- Ability to deliver quality outputs under minimal supervision.