Sr Quality Software Engineer

Job Title: Sr Quality Software Engineer
Job ID: 37700306
Location: Austin TX 78744
Duration:12 months

Role Summary

Senior Software Validation & Quality Engineer supportingregulated medical-device software. Responsible for software quality reviews,V&V/validation, Design Controls, risk management, traceability, testing, change control, and audit readiness.

Must-Have Requirements

• Bachelor’s degree + 4+ years relevant experience or equivalent.
• 4+ yearsSoftware Validation / Software Quality experience in a regulated environment; medical device preferred.
• Strong experience withSoftware V&V and validation testing.
• Experience reviewingsoftware requirements, design, test plans, validation protocols, RTMs, and validation reports.
• Strong understanding ofDesign Controls and software lifecycle quality processes.
• Experience withrequirements-to-risk-to-test traceability and objective evidence.
• Experience withrisk management / risk assessments, preferablyISO 14971.
• Experience withchange control and impact assessments.
• Experience with functional, integration, and system-level testing ofembedded and/or cloud software.
• Strong technical documentation, defect investigation, RCA, and audit-readiness skills.
• Ability to work cross-functionally withR&D, Software Engineering, QA and Regulatory.
• Onsite Austin, TX – 5 days/week required.