Software Quality Engineer III

*Create and maintain requirements tracing in Cognition Cockpit *Assist team in translating offline efforts for requirements/RCM/DOSR to Cognition Cockpit *Establish and maintain end-to-end traceability across: oUser Needs oIntended Use and Product Claims oSystem and Subsystem Requirements oDesign Inputs and Outputs oRisk Controls oVerification Activities oValidation Activities oRegulatory Requirements *Review requirements documentation to ensure clarity, completeness, testability, and compliance with internal standards. *Develop and maintain traceability matrices and requirements management artifacts supporting Design History Files (DHF). *Partner with cross-functional teams to ensure design changes are assessed for traceability impacts and appropriate updates are implemented. *Facilitate requirements reviews and traceability assessments throughout product development and integration activities. *Support gap assessments to identify missing, incomplete, or improperly linked requirements and verification evidence. *Verify that requirements are appropriately linked to verification and validation activities and that objective evidence exists demonstrating compliance. *Support regulatory submissions, audits, and inspections by providing traceability documentation and rationale. *Collaborate with Risk Management teams to ensure hazards, hazardous situations, and risk control measures are properly traced to design requirements and testing.

Quality Systems Duties and Responsibilities: Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

Bachelor’’s degree in EE or SW Engineering. 5 years w/bachelor’’s degree and 3 with Masters. Medical device experience Requirements tracing experience