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Senior Software Quality Assurance Engineer

Senior Software Quality Assurance Engineer

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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 companys 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

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