Senior Quality Engineer

Tempus

Chicago, Illinois, US
Base: chicago $90,000-$130,000; nyc/sf $100,000-$1...
Hybrid
Computer system validation csv experience
Fda quality system regulation knowledge
Medical device software design controls
This role involves leading the verification and validation of host systems supporting Tempus Medical Devices in a hybrid work environment

Job Summary

  • This role involves leading the verification and validation of host systems supporting Tempus Medical Devices in a hybrid work environment.
  • Candidates must possess deep expertise in Computer System Validation (CSV) and regulatory standards such as FDA 21 CFR Part 11 and ISO 13485.
  • The position offers competitive compensation ranging from $90,000 to $150,000 depending on location, along with comprehensive benefits including incentive compensation.

Matching Summary

This role involves leading the verification and validation of host systems supporting Tempus Medical Devices in a hybrid work environment.

Salary

Base: Chicago $90,000-$130,000; NYC/SF $100,000-$150,000; Bonus/Equity: Incentive compensation and restricted stock units available; Benefits: Full range including medical and other benefits

Skills & Requirements

Must-have

  • Computer System Validation CSV experience
  • FDA Quality System Regulation knowledge
  • Medical device software design controls
  • Risk assessment and testing strategies
  • GAMP5 and ISO 13485 standards

Nice-to-have

  • AI application validation experience
  • Cross-functional team collaboration
  • Mentorship and training capabilities
  • Change management process support

Key Requirements

  • BA/BS degree in relevant engineering discipline
  • 5+ years experience in FDA regulated domain
  • 3+ years experience in Computer System Validation

Work Rights

Not specified

Tailored Resume

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