Job Description
Job Title: Sr Quality Software Engineer
Job ID: 37700306
Location: Austin TX 78744
Duration:12 months
Role Summary
Senior 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 Requirements
- Bachelor’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.
Skills
Change Controlunmatched
Cloud Computingunmatched
Code Reviewsunmatched
Cross-Functionalunmatched
Embedded Softwareunmatched
Healthcare Softwareunmatched
ISO (International Organization for Standardization)unmatched
Medical Equipmentunmatched
Quality Engineeringunmatched
Regulationsunmatched
Research & Development (R&D)unmatched
Riskunmatched
Risk Analysisunmatched
Risk Managementunmatched
Software Designunmatched
Software Development Lifecycle (SDLC)unmatched
Software Engineeringunmatched
Software Testingunmatched
Software Validationunmatched
System Testunmatched
Technical Writingunmatched
Test Designunmatched
Testingunmatched
Traceabilityunmatched
V&V Testingunmatched
Validation Planunmatched
Validation Testingunmatched
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