Sr. Quality Engineer
Core
Senior Quality Engineer managing QMS, SDLC tools, and computer system validation (CSV) for FDA-regulated medical device software.
Role type
Senior IC Quality Engineer (Medical Device/Regulatory)
Builds
Compliant software tools and systems for Tempus' precision medicine platform
Domain
Healthcare / Medical Device / Regulatory Compliance
Required skills
Computer System Validation (CSV), FDA QSR, ISO 13485, 21 CFR Part 11, SDLC tool management, Risk Management (ISO 14971), Design History File (DHF) support, FMEA, Agile/Scrum
Preferred skills
Biomedical or Software Engineering degree, Experience with eTQ and JAMA/JIRA
Technologies
eTQ, JAMA, JIRA, Atlassian
Responsibilities
Manage implementation and maintenance of QMS and SDLC tools; Perform and support CSV activities and testing against user requirements; Support medical device software design controls (DHF, FMEA, risk management); Write SOPs and CSV deliverables; Facilitate UAT and system training; Drive validation compliance to auditors and regulatory authorities.
Seniority
Senior, hands-on IC