Senior Quality Assurance Engineer

1 week ago


Chicago, Illinois, United States Tempus Full time
Job Summary

We are seeking a highly skilled Senior Quality Assurance Engineer to join our team at Tempus. As a key member of our quality team, you will be responsible for leading the verification, validation, and maintenance of host and computer systems supporting our medical devices.

Key Responsibilities:

  • Lead risk assessments to determine testing strategies
  • Develop and maintain Computer System Validation (CSV) policies, procedures, and work instructions
  • 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, Validation Protocols, and Validation Reports

Requirements:

  • BA/B.S. or higher 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)

At Tempus, we are committed to delivering high-quality products and services that meet the needs of our customers. If you are a motivated and detail-oriented individual with a passion for quality assurance, we encourage you to apply for this exciting opportunity.



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