Sr Quality Engineer, Critical Systems
Core
Develops and evaluates manufacturing quality and system standards, investigates validation issues, and verifies instrument maintenance to ensure reliability and regulatory compliance.
Role type
Senior IC Quality Engineer (Critical Systems)
Builds
Manufacturing quality standards, validation procedures, and technical reports for systems and processes
Domain
Life Sciences / Medical Devices / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Statistical analysis, Validation troubleshooting, Regulatory compliance, Instrument calibration verification, Corrective action planning, Documentation writing and review
Preferred skills
Establishing corporate validation policies
Technologies
None stated
Responsibilities
Develop and evaluate quality and system standards; Investigate and troubleshoot validation discrepancies; Conduct statistical analyses of testing results and process anomalies; Write, review, approve, and execute validation procedures and technical reports; Ensure corrective measures meet reliability standards; Verify calibration, maintenance, and repair of instruments
Seniority
Senior, hands-on IC
