AI Quality Engineer

About the Role The AI Quality Engineer leads QA for AI‑driven medical device software, overseeing end‑to‑end lifecycle and regulatory compliance for AI/ML models to ensure safety and effectiveness. This role partners with R&D, clinical, regulatory, and product teams to guide AI/ML solutions through rigorous quality processes. This on‑site position reports to the Director, Quality Assurance and Regulatory Compliance in Vista, CA. What You'll Do

• Represent the Quality Engineering function on cross‑functional teams, contributing to design controls, process controls, verification/validation activities, and Design History File development.
• Lead development and execution of AI/ML quality assurance strategies aligned with global regulations and standards (FDA, MDR, IVDR, IEC 5338, IEC 23053, EC 8183, IEEE 2801, ISO 13485, IEC 62304).
• Partner with data scientists, software engineers, and clinical experts to ensure AI/ML solutions meet clinical, regulatory, and performance expectations.
• Support global regulatory submissions, such as FDA pre‑subs, 510(k), and IVDR CE, while driving AI/ML risk management, including hazard analysis, mitigation planning, and evaluation of model robustness, bias, and fairness.
• Lead AI/ML lifecycle quality activities, including V&V best practices, CAPA and root‑cause investigations, audit/inspection readiness, and mentoring of junior engineers while staying current on evolving regulatory and industry trends. What We're Looking For
• Bachelor’s or master’s degree in computer science, Data Science, Artificial Intelligence or a related technical field; advanced degree preferred, with 5+ years of quality experience in medical devices, IVD, or similarly regulated industries.
• Deep expertise in AI/ML algorithms, model validation, evaluation techniques, and regulated software or embedded software development.
• Strong knowledge of regulatory standards for AI/ML and SaMD, including FDA 21 CFR Part 820, IEC 5338, ISO 13485, IEC 62304, and FDA AI/ML guidance.
• Proven ability to lead AI‑focused risk management processes, supported by strong analytical skills and a commitment to patient safety and product quality.
• Demonstrated leadership, project management, and communication skills, with experience across AI/ML, Digital Health, Cybersecurity, and Interoperability. Nice to Have
• Familiarity with Good Machine Learning Practices (GMLP) and FDA’s AI/ML regulatory framework.
• Experience with post-market surveillance and monitoring of AI/ML models.
• Knowledge of digital health, cybersecurity, interoperability, and cloud-based SaMD deployment considerations.
• Effective presentation and communication skills, with ability to engage both technical and non-technical stakeholders.
• Strong organizational and project management skills to meet regulatory and product development timelines. Compensation & Benefits
• The annual salary range for this role is $160,000 - $180,000. This role is eligible for bonus/incentive pay.
• Comprehensive benefits including paid time off, medical/dental/vision insurance, and 401(k); benefits details available through the company.
• Note: Pay and benefits are determined at the company’s discretion and may be modified over time.