Quality Systems & Compliance Lead for SaMD & AI/ML

Verily Health

Dallas (TX)

On-site

USD 142,000 - 213,000

Full time

14 days+

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Job summary

Verily Health is seeking a Quality Systems and Compliance Lead to own one or more QA domains and drive strategic initiatives across engineering, product, and operations. This role ensures products spanning consumer health, research tools, and medical devices meet quality, reliability, and regulatory standards.

You will lead the QMS, maintain ISO 13485:2016 certification, and shape AI/ML governance within a compliant framework.

Qualifications

Bachelor's degree in a scientific, engineering, or related field with 8+ years of experience in quality assurance or regulatory affairs within the medical device, digital health, or life sciences industry.
Experience leading or managing a QMS in conformance with ISO 13485:2016 and FDA QMSR across multiple product domains, including hands-on experience with design and development, CAPA, risk management processes per ISO 14971 and medical device software lifecycle processes per IEC 62304.

Responsibilities

Leads the ongoing vision and implementation of the Quality Management System (QMS) across consumer, research, and medical device domains, including AI/ML and generative AI products, in conformance with GMP, GCP, GCLP, and GLP requirements.
Develops and advances quality oversight frameworks for AI/ML and generative AI products, including model validation, monitoring, and change protocols in line with FDA guidance.
Maintains ISO 13485:2016 certification and supports expansion to additional certifications like MDSAP; analyzes metrics to drive CAPA and continuous improvement.