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 software quality management system (QMS) and software development life cycle (SDLC) activities, in accordance with FDA’s Quality System Regulation (QSR), ISO 13485, Computer System Validation (CSV) and other applicable regulatory requirements, as well as best practices in the software industry. This position will report to the VP of Quality Assurance.
- Support Tempus’ SDLC activities for medical device software, Software as a Medical Device (SaMD), and Computer System Validation (CSV) projects.
- Provide FDA/ISO Design Controls and CSV training and mentoring to the software, bioinformatics and IT teams.
- Ensure required documentation and DHF deliverables are generated and maintained throughout SDLC of medical device software/SaMD, including SRS, SAD, SDS, V&V, trace-ability, risk management/FMEA and cyber-security.
- Ensure required documentation and CSV deliverables are generated and maintained throughout SDLC of in-house developed and OTS computer systems, including Validation Plan, Validation Risk Assessment, 21 CFR Part 11 assessment, User Requirement Specifications (URS), Validation Protocol, Trace Matrix, Validation Summary Report (VSR), IQ/OQ/PQ.
- Apply innovative, scalable and risk-based approaches to meeting compliance for novel technologies in a fast-paced, multi-project environment.
- 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.
- Support compliance to various QMS procedures and activities including but not limited to: risk management, CAPAs, complaint/defect root-cause investigations, internal and external audits, management reviews, change control, training.
- 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, ISO 13485, IEC 62304, ISO 14971, CSV, 21CFR Part 11.
- Expertise in SDLC best practices, and experience with state-of-the-art SDLC tools such as Atlassian (JIRA), and JAMA.
- Experience with Agile/Scrum/iterative software development methodology.
- Excellent organizational, interpersonal, verbal and written communication skills
- Ability to deliver quality outputs under minimal supervision.