Senior Software Quality Engineer
Job in
Austin, Travis County, Texas, 78716, USA
Listed on 2026-09-14
Listing for:
Skills Alliance
Full Time
position Listed on 2026-09-14
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering
Job Description & How to Apply Below
Senior Software Quality Engineer x2 | Surgical Robotics
A global medical technology leader, nearly 100 years in the industry. Every 8 seconds, one of their products or technologies helps improve someone's mobility.
This role sits within the Monogram Technologies robotics team. You will review and support software quality across the development lifecycle, working closely with R&D, QA, and Regulatory. You'll help keep the team audit ready and compliant with FDA, ISO, and IEC standards.
What you will own:- Reviewing requirements, design, and deliverables for compliance with FDA, ISO, and IEC 62304
- Reviewing and approving requirement specs, test plans, validation protocols, and traceability matrices (RTM)
- Ensuring traceability between requirements, risk controls, and verification evidence
- Supporting risk assessments and verifying risk control measures
- Taking part in design reviews, code reviews, and quality reviews
- Supporting change management, including impact assessment
- Developing and running test plans, test cases, and validation protocols
- Running functional, integration, and system level testing for embedded and cloud based software
- Supporting audit readiness and regulatory inspections
- Bachelor's degree in Computer Science, Computer Engineering, or related field
- 4+ years of software validation and quality experience in a regulated environment (medical device preferred)
- Strong grasp of V&V principles, test coverage, and objective evidence
- Experience with risk management (ISO 14971)
- Knowledge of FDA regulations, IEC 62304, GAMP 5, and 21 CFR Part 11
- Experience working cross functionally with R&D, QA, and Regulatory
Position Requirements
10+ Years
work experience
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