Senior Quality Engineer, Medical Device CSV | Hybrid

Tempus AI; Chicago (IL); Hybrid; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

Tempus AI is seeking a Senior Quality Engineer to lead verification, validation and maintenance of host systems supporting Tempus Medical Device software. You will drive CSV activities, risk assessments, and compliance with FDA QSR, ISO 13485 and related standards.

The role is hybrid with three days in the Chicago office (HQ) or Aliso Viejo, CA. You will collaborate with cross-functional teams to define testing strategies and ensure regulatory readiness.

Qualifikationen

• BA/BS 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).
• Experience with industry standards and best practices for Medical device software and CSV such as Design Controls, GAMP 5, FDA 21 CFR Part 11, FDA (QSR) FDA 21 CFR 820.30, Medical device software (QMS) ISO 13485:2016, FDA 21 CFR 820, and Software life cycle processes (IEC 62304:2006).
• Knowledge of quality system principles, practices, and standards for the life science industry.
• Ability to deliver quality outputs without directions or under minimal supervision.

Aufgaben

• Lead verification, validation and maintenance of host systems supporting Tempus Medical Device(s).
• Lead risk assessments to determine testing strategies.
• Be involved in the medical device software design controls activities, in accordance with regulatory requirements and best practices.
• Lead computer system validation (CSV) activities of Tempus AI applications, software tools, and computer systems against requirements.
• Collaborate with cross-functional teams in developing test-driven system/functional requirements, testing strategies and test execution.
• Support Change Management and Major Incidents processes to ensure compliance and continuous improvement.
• Provide CSV guidance, coaching, and training to test engineers.

Kenntnisse

FDA regulated domain

CSV

Design Controls

Medical device software

Quality system principles

Ausbildung

BA/BS in Computer Science or related

Tools

GAMP 5

ISO 13485

Jobbeschreibung

Tempus AI is seeking a Senior Quality Engineer to lead verification, validation and maintenance of host systems supporting Tempus Medical Device software. You will drive CSV activities, risk assessments, and compliance with FDA QSR, ISO 13485 and related standards.

The role is hybrid with three days in the Chicago office (HQ) or Aliso Viejo, CA. You will collaborate with cross-functional teams to define testing strategies and ensure regulatory readiness.