Staff Software Quality Engineer
$127,000–$165,000 year
Hybrid · California, United States
Job Summary
Staff Software Quality Engineer leads CSA strategy and validation for non-product software used in medical-device manufacturing. Responsible for strategy and validation master plans, risk-based testing to determine validation rigor for manufacturing, QMS, and development tools, and ensuring compliance with 21 CFR Part 11 and ISO 13485. Will review/author validation plans, software V&V, IQ/OQ/PQ protocols, and participate in tool qualification of software-based test, manufacturing, and processing equipment. Collaborates with Manufacturing, IT, DevOps, and R&D to implement compliant workflows and acts as technical lead during internal/external audits. Will manage software changes via configuration management and support regulatory readiness. Preferred skills include SaMD/AI-enabled medical devices. Work environment is iOC based Hybrid with minimum 3 days on site in Orange County, CA.
Required Qualifications
- Bachelor's degree in Computer Science, Biomedical Engineering, or related technical field
- 12 years of related experience with a Bachelor's degree; or 8 years with a Master's degree; or equivalent work experience
- Knowledge of FDA 21 CFR Part 820, Part 11, IEC 62304, and GAMP5
- Experience validating custom software and tools for device manufacturing and processing
- Experience with DevOps toolchains (e.g., Jira, Git) and test automation
- Strong cross-functional leadership and communication skills
- Ability to mentor junior engineers and lead audits
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