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 builds AI-enabled precision medicine tools and genomic tests used by physicians and health systems, with a core focus on oncology. It sells diagnostics, clinical decision-support software, and real‑world data services to providers and biopharma for drug discovery and trials. Founded in 2015 and headquartered in Chicago, Tempus is a public company listed on Nasdaq.