We are looking for a Senior Quality Engineer (Software Design Controls) who will be involved in quality management system (QMS) and software development life cycle (SDLC) activities, 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 is within the Tempus Quality Assurance (QA) group.
Responsibilities
● Support Tempus’ SDLC activities for medical device software and Software as a Medical Device (SaMD).
● Support Tempus’ QMS activities by maintaining relevant procedures, identifying improvement opportunities, and providing training
● Ensure required documentation and DHF deliverables are generated and maintained throughout SDLC of medical device software/SaMD, including SRS, SAD, SDS, V&V, traceability, risk management/FMEA, and cybersecurity.
● 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.
Preferred Qualifications
● BA/B.S. or higher preferred in Computer Science, Software Engineering, 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
● Expertise in SDLC best practices, and experience with industry 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.
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