Remote Senior Software Quality Engineer Position at Tempus

Date Posted: Sep 09, 2024

Location: USA

Join Tempus and Impact Precision Medicine

Are you passionate about precision medicine and advancing the healthcare industry? At Tempus, we leverage cutting-edge technology to bring meaningful AI advancements to clinical care. Our proprietary platform connects a vast ecosystem of real-world evidence, delivering real-time, actionable insights to physicians. This ensures the right treatments are provided to the right patients at the right time.

About the Role: Senior Software Quality Engineer

We're seeking a remote Senior Software Quality Engineer (Software Design Controls) to join our team. This role involves active participation in the software quality management system (QMS) and the software development life cycle (SDLC), conforming to FDA’s Quality System Regulation (QSR), ISO 13485, CAP/CLIA, and other regulatory standards. Reporting to the Manager of Software Quality, you will significantly contribute to delivering high-quality software products.

Key Responsibilities

• Lead software quality efforts for Tempus’ SDLC projects, including laboratory-developed tests, investigational device software, and commercialization of medical devices (SiMD and SaMD).
• Mentor cross-functional teams, such as R&D, lab operations, software engineering, bioinformatics, and IT, on FDA/ISO Design Controls.
• Ensure generation and maintenance of essential quality documentation throughout the SDLC, including SRS, SAD, SDS, V&V, traceability, risk management/FMEA, and cyber-security.
• Implement innovative, scalable, and risk-based approaches to compliance in a fast-paced, multi-project environment.
• Stay updated on the evolving regulatory landscape for Digital Health, Artificial Intelligence, and Machine Learning, and incorporate best practices into Tempus’ SDLC processes and QMS.
• Support compliance with various QMS procedures, including risk management, internal and external audits, change control, and training.
• Own and support software QMS procedures.
• Perform other related duties as assigned.

Required Education & Experience

• BA/B.S. or higher in Computer Science, Software Engineering, Informatics, Biomedical, or relevant engineering disciplines.
• Over 5 years of experience in a software quality (design assurance/controls) role within the medical device/IVD or FDA-regulated industry.
• In-depth knowledge of applicable regulations and standards: FDA QSR, ISO 13485, IEC 62304, ISO 14971.
• Expertise in SDLC best practices and experience with SDLC tools such as Atlassian (Jira) and Jama.
• Proficiency in Agile/Scrum/iterative software development methodologies.
• Ability to deliver quality work with minimal supervision.

We are an equal opportunity employer and do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.