Software Quality Engineer III

Collaborate with Risk Management teams to ensure hazards, hazardous situations, and risk control measures are properly traced to design requirements and testing. •Partner with cross-functional teams to ensure design changes are assessed for traceability impacts and appropriate updates are implemented.

Description:
Key Responsibilities
•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.

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