over 1 year ago
Base Salary
$100k - $150k/yr
Responsibilities
- Support SDLC activities for medical device software and SaMD.
- Maintain QMS procedures and identify improvement opportunities.
- Generate and maintain required documentation throughout the SDLC.
- Apply risk-based approaches to compliance for novel technologies.
- Stay informed on regulatory changes in Digital Health and AI.
- Support compliance with QMS procedures including risk management and audits.
Requirements
- BA/B.S. or higher in Computer Science, Software Engineering, Biomedical, or relevant engineering disciplines preferred.
- 5+ years in a software quality role in the medical device or FDA regulated industry.
- Knowledge of FDA QSR, ISO 13485, IEC 62304, and ISO 14971 regulations.
- Expertise in SDLC best practices and experience with tools like Jira and Jama.
- Experience with Agile/Scrum methodologies.
- Strong organizational, interpersonal, and communication skills.
Categories
About Tempus
Tempus is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. With one of the world’s largest libraries of multimodal data, and an operating system to make that data accessible and useful, Tempus provides AI-enabled precision medicine solutions to physicians to deliver personalized patient care and in parallel facilitates discovery, development and delivery of optimal therapeutics. The goal is for each patient to benefit from the treatment of others who came before by providing physicians with tools that learn as the company gathers more data. For more information, visit tempus.com.