Senior Software Quality Assurance Engineer

Job Description

Senior Software Quality Engineer

San Diego, CA | Full-Time

A fast-growing medical device company in San Diego is hiring a Senior Software Quality Engineer . This is their first dedicated software quality hire, an autonomous role building the function from the ground up. You’ll be the quality lead on software development for regulated devices, covering embedded, application and cloud-based systems.

What You’ll Do

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• Develop and maintain software quality assurance strategies, plans and procedures in line with FDA, ISO 13485 and IEC 62304
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• Own software validation and traceability from requirements through code for product and non-product software
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• Lead quality review of test plans, test cases and automation scripts across unit, integration, system and regression testing
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• Lead defect management, including reviewing, dispositioning and verifying the resolution of software defects
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• Participate in design reviews, code reviews and technical assessments to identify quality risks early
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• Perform software risk analysis, develop mitigations and maintain software and system-level risk management files
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• Partner with cybersecurity and engineering teams on quality rigor for cloud and local data and patient-facing software
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• Drive root cause analysis and CAPA for software defects, nonconforming product and customer complaints
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• Conduct supplier audits and support internal and third-party audits as the software quality subject matter expert
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• Write and maintain SOPs, train cross-functional teams and drive continuous improvement in software quality processes, tools and metrics
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What You’ll Bring

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• Bachelor’s or Master’s degree in Computer Science, Software Engineering, Biomedical Engineering or a related field
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• 5+ years of experience in software quality assurance or software engineering
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• Software background, with the ability to read and understand code
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• Hands-on software validation experience, including experience developing software risk management files
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• Working knowledge of cybersecurity fundamentals
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• Understanding of large-scale/cloud data vs. local data and patient-facing software interactions
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• Working knowledge of FDA 21 CFR Part 820, ISO 13485 and IEC 62304
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• Understanding of SDLC methodologies (Agile, Waterfall) in a regulated environment
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• Combined medical device and pharma/combination product experience is a plus
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Logistics

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• Base salary: $170K–$180K
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• Location: San Diego, CA (onsite initially, hybrid flexibility once established)
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• Travel: up to 10%
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