Sr Quality Software Engineer

Job Title: Sr Quality Software EngineerJob ID: 37700306Location: Austin TX 78744Duration:12 monthsRole SummarySenior Software Validation & Quality Engineer supporting regulated medical-device software. Responsible for software quality reviews, V&V/validation, Design Controls, risk management, traceability, testing, change control, and audit readiness.Must-Have RequirementsBachelor's degree + 4+ years relevant experience or equivalent.4+ years Software Validation / Software Quality experience in a regulated environment; medical device preferred.Strong experience with Software V&V and validation testing.Experience reviewing software requirements, design, test plans, validation protocols, RTMs, and validation reports.Strong understanding of Design Controls and software lifecycle quality processes.Experience with requirements-to-risk-to-test traceability and objective evidence.Experience with risk management / risk assessments, preferably ISO 14971.Experience with change control and impact assessments.Experience with functional, integration, and system-level testing of embedded and/or cloud software.Strong technical documentation, defect investigation, RCA, and audit-readiness skills.Ability to work cross-functionally with R&D, Software Engineering, QA and Regulatory.Onsite Austin, TX - 5 days/week required.