Quality Systems Lead in SaMD & AI/ML Compliance

Verily Health; San Bruno (CA); On-site; USD 142,000 - 213,000; Full time

Job summary

Verily Health is seeking a Quality Systems and Compliance Lead to own one or more QA domains across consumer health, research tools, and medical devices. The role requires leadership of complex quality initiatives with regulatory impact.

You will design, implement, and maintain a robust QMS aligned with ISO 13485:2016, drive CAPA programs, and coordinate with engineering, product, and operations to embed quality into development for AI/ML and SaMD products.

Qualifications

• 8+ years of experience in quality assurance or regulatory affairs in medical devices or digital health.
• Experience leading a QMS in ISO 13485:2016 and FDA QMSR across multiple product domains.
• Experience with SaMD and/or AI/ML-enabled products and relevant FDA guidance.
• Proven ability to lead cross-functional QA initiatives and develop teams.

Responsibilities

• Lead the QMS vision and implementation across consumer, research, and medical device quality.
• Develop QA frameworks for AI/ML and generative AI products aligned with regulatory guidance.
• Maintain ISO 13485:2016 and pursue MDSAP certification as needed.
• Coach and grow the QA team and promote a compliant culture.

Skills

Quality leadership

Regulatory affairs

Cross-functional collaboration

GxP training

Education

Bachelor's degree in a scientific, engineering, or related field

Advanced degree (MS/MPH/PhD) or QA certification

Tools

Jira

GitHub

Job description

Verily Health is seeking a Quality Systems and Compliance Lead to own one or more QA domains across consumer health, research tools, and medical devices. The role requires leadership of complex quality initiatives with regulatory impact.

You will design, implement, and maintain a robust QMS aligned with ISO 13485:2016, drive CAPA programs, and coordinate with engineering, product, and operations to embed quality into development for AI/ML and SaMD products.