Software Quality Engineer II
$75,000–$100,000 year
On-site · Irvine, California, United States
Job Summary
Software Quality Engineer II responsible for overseeing software quality throughout the product lifecycle for medical device software. Works with Software Engineering, Systems Engineering, Regulatory Affairs, and Product Development to ensure compliance, risk management, and effective lifecycle processes from concept to commercialization. Responsibilities include reviewing software design and development deliverables, supporting verification and validation activities, managing design control per FDA/ISO standards, participating in CAPA and post-market quality processes, and driving continuous improvement of quality systems. Requires knowledge of medical device regulations (FDA 21 CFR Part 820, ISO 13485, IEC 62304, ISO 14971), SDLC, and cross-functional collaboration; mentorship of junior team members and support for internal/external audits and regulatory inspections.
Required Qualifications
- Bachelor’s degree in Computer Science, Software Engineering, Electrical Engineering, Biomedical Engineering, or related technical discipline
- Minimum 3 years of experience in Quality Engineering, Quality Assurance, or Software Quality within a regulated industry
- Working knowledge of SDLC, Agile and/or waterfall development methodologies
- Experience supporting software verification and validation activities
- Knowledge of medical device regulations and standards such as FDA 21 CFR Part 820, ISO 13485, IEC 62304, and ISO 14971
- Experience with change control, nonconformance, CAPA, and complaint handling processes
- Strong analytical, problem-solving, and risk assessment skills
- Strong written and verbal communication skills with the ability to work cross-functionally
- Proficiency with Microsoft Office applications and quality documentation systems
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