Senior Software Quality Engineer

Skills Alliance; Austin (TX); On-site; USD 110,000 - 140,000; Full time

Job summary

Skills Alliance seeks a Senior Software Quality Engineer for Surgical Robotics within the Monogram Technologies robotics team in Texas. You will review and support software quality across the development lifecycle, collaborating with R&D, QA, and Regulatory to ensure FDA/ISO/IEC compliance.

This role emphasizes audit readiness, traceability, risk management, and hands-on validation across embedded and cloud-based software, with opportunities during regulatory inspections.

Qualifications

• Bachelor's degree in Computer Science, Computer Engineering, or related field.
• 4+ years of software validation and quality experience in a regulated environment.
• 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.

Responsibilities

• 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

Skills

FDA/quality

V&V principles

Cross-functional collaboration

Education

Bachelor's degree in Computer Science/Computer Engineering

Job description

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

What you must have:

• 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