Head of Quality Systems and Compliance (AI/SaMD)

Verily Health; Boston (MA); On-site; USD 142,000 - 213,000; Full time

Job summary

Verily Health is seeking a Quality Systems and Compliance Lead to own QA across consumer health, research tools, and medical devices, guiding quality systems and ensuring compliance with global standards. You will architect robust QA processes and drive strategic QA initiatives with measurable impact, coordinating with engineering, product, and operations teams.

Key focus areas include ISO 13485:2016 certification, FDA QMSR alignment, CAPA and risk management, and governance for AI/ML-enabled

Qualifications

• 8+ years of QA or regulatory affairs in medical devices, digital health, or life sciences.
• Experience leading a QMS per ISO 13485:2016 and FDA QMSR across multiple product domains.
• Experience with SaMD and AI/ML-enabled products and applicable FDA guidance.
• Strong cross-functional leadership across engineering, product, and clinical teams.

Responsibilities

• Define and advance quality management system strategy across consumer, research, and medical device domains.
• Lead quality planning with cross-functional stakeholders for SaMD and AI/ML products.
• Maintain ISO 13485:2016 certification and drive CAPA and risk management.
• Build and mentor a QA team and promote a culture of compliance.
• Embed quality into software development workflows using Jira, GitHub, and related tools.

Skills

Quality Assurance

QMS

ISO 13485

FDA QMSR

CAPA

Risk management

Regulatory affairs

SaMD

AI/ML quality

GxP

Education

Bachelor's degree in science/engineering or related field

Tools

Jira

GitHub

Google Workspace

Job description

Verily Health is seeking a Quality Systems and Compliance Lead to own QA across consumer health, research tools, and medical devices, guiding quality systems and ensuring compliance with global standards. You will architect robust QA processes and drive strategic QA initiatives with measurable impact, coordinating with engineering, product, and operations teams.

Key focus areas include ISO 13485:2016 certification, FDA QMSR alignment, CAPA and risk management, and governance for AI/ML-enabled