California Licensed Quality Engineer

Job Summary

As the senior technical authority for software quality and design excellence, the full-time California Licensed Quality Engineer will oversee the end-to-end design control process within the Software Development Lifecycle (SDLC), ensuring compliance with global regulatory standards while driving quality engineering practices across multiple product lines in a hybrid work environment.

Key Responsibilities

• Lead the application of global regulatory standards and monitor changes to update internal practices
• Architect validation frameworks for AI/ML and Cybersecurity within the Quality Management System (QMS)
• Define and champion Compliance at Speed frameworks to ensure Agile sprints meet regulatory rigor

Required Qualifications

• Bachelor's degree in Software Engineering, Computer Science, Biomedical Engineering, or a related technical field
• 10+ years of experience in quality engineering or product development in the medical device industry
• At least 3 years in a senior or lead quality engineering role for Software as a Medical Device (SaMD) or AI/ML-enabled products
• Preferred certifications: ASQ Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), or Black Belt
• Master's degree in a relevant technical or quality discipline preferred