Remote Senior Quality Engineer

Summary

Join a team passionate about precision medicine and advancing the healthcare industry as a Senior Software Quality Engineer. Lead verification, validation, and maintenance of host and computer systems supporting Tempus Medical Device(s).

Requirements

• BA/B.S. or higher preferred in Computer Science, Software Engineering, Informatics, Biomedical, or relevant engineering disciplines
• 5+ years experience in FDA regulated domain (e.g. medical device, pharma, biotech)
• 3+ years experience in Computer System Validation (CSV)
• Experience with industry standards and best practices for Medical device software and CSV such as Design Controls, GAMP 5, FDA 21 CFR Part 11, FDA (QSR) FDA 21 CFR 820.30, Medical device software (QMS) ISO 13485:2016, FDA 21 CFR 820, and Software life cycle processes (IEC 62304:2006)
• Knowledge of quality system principles, practices, and standards for the life science industry
• Ability to deliver quality outputs without directions or under minimal supervision

Responsibilities

• Lead verification, validation and maintenance of host and computer systems supporting Tempus Medical Device(s)
• Lead risk assessments to determine testing strategies
• Be involved in the medical device software design controls activities, in accordance with the FDA Quality System Regulation, ISO 13485, GAMP5, Computer System Validation (CSV) standards and FDA guidance, other applicable regulatory requirements, as well as best practices in the software industry
• Lead computer system validation (CSV) activities of AI applications, software tools, and computer systems against user, functional and regulatory requirements
• Support regulatory compliance of the host system operating with Tempus Medical Device(s) (e.g. xT CDx)
• Develop and maintain CSV policies, procedures, templates and work instructions
• Lead risk-based approach to host / computer system validation (HSV/CSV), SDLC and design controls activities
• Perform validation, re-validation and change controls of various AI, SaaS/OTS, and Tempus in-house developed software
• Author and review software validation deliverables, including Risk Assessments, Validation Plans, Requirements (URS), Validation Protocols (IQ, OQ, PQ), UAT (User Acceptance Test), and Validation Reports
• Collaborate with cross-functional teams in developing test-driven system/functional requirements, defining testing strategies and participating in test execution
• Support Change Management and Major Incidents (MI) processes, ensuring organizational compliance and continuous improvement
• Provide support to Quality and IT organizations in maintaining compliance to various policies, procedures and activities, including support during internal/external inspections and regulatory and customer audits
• Provide CSV guidance, coaching, mentorship, and training to test engineers within the team

Benefits

This position may be remote