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Senior Software Quality Assurance Engineer Senior Software Quality Assurance Engineer Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Skills Alliance Principal Recruitment Consultant - Medical Device Senior Software Quality Assurance Engineer – Medical Devices Austin, TX | Full-Time A cutting-edge medical device company is seeking a Senior Software Quality Engineer to support the full lifecycle of software development and post-market activities. This role is essential in ensuring compliance with the company’s Quality Management System (QMS) and global regulatory standards. Key Responsibilities: Lead and support design control and risk management deliverables Review and guide software V&V protocols, requirements traceability, and defect resolution Audit and monitor software activities governed by QMS procedures Provide statistical analysis and quality input for design transfer, process validation, and manufacturing Collaborate across hardware, software, and regulatory teams to ensure quality integration Support regulatory filings (510(k) vs Letter to File) and participate in design validation/usability studies Qualifications: BS in Engineering (software/mechanical/electrical) 7+ years in Quality Engineering, including software V&V 5+ years in medical devices; robotics experience is a plus Strong knowledge of FDA/ISO standards (21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304) Experience with tools like Jira, Confluence, Jama, Greenlight Guru, Excel macros Familiarity with Agile/Scrum and cybersecurity in medical devices is preferred Join a dynamic team shaping the future of surgical robotics and digital health! Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Quality Assurance Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Skills Alliance by 2x Sign in to set job alerts for “Software Quality Assurance Engineer” roles. Quality Assurance Engineer I, Amazon Key Software Development Engineer in Test – 2025 (US) Austin, TX $105,000.00-$185,000.00 1 week ago Quality Assurance Engineer II, Amazon Key QA automation engineers (In-Person at TX) QA Test Engineer, Software, Mobile Applications Software Quality Assurance Tester Consultant for Texas Education Agency, Austin, Tx Austin, Texas Metropolitan Area 1 day ago Austin, Texas Metropolitan Area 1 day ago Austin, TX $152,500.00-$262,350.00 1 month ago AVP Software Development Engineer in Test Austin, TX $119,400.00-$199,000.00 4 days ago QA Engineer Automated 3 Consultant for Texas Education Agency, Austin, Tx Austin, TX $100,000.00-$135,000.00 4 weeks ago Austin, TX $152,500.00-$262,350.00 1 month ago Senior Software Engineer in Test, Machine Learning Software Development Engineer-Test, Amazon Customer Service Software Quality Assurance Engineer, Trilogy (Remote) - $60,000/year USD Austin, TX $124,700.00-$180,650.00 1 week ago Java Software Development Engineer in Test Austin, TX $63,400.00-$135,000.00 5 days ago Embedded Quality Assurance Engineer III, Quality Assurance, 3rd Eye We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr