Quality Systems and Compliance Lead

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

Who We Are

Verily Health is a data platform and technology company purpose-built to power AI-enabled precision health solutions that accelerate research and improve care for individuals and communities. Uniquely positioned at the intersection of technology, data science, and healthcare, Verily transforms multimodal health data into insights, models, and actions that make healthcare more personalized, predictive, and precise.

Description

The Quality Systems and Compliance Lead drives quality excellence at Verily by owning one or more Quality Assurance domains and leading strategic QA initiatives with measurable impact. This role is responsible for designing and advancing robust quality systems and serves as a key liaison across engineering, product, and operations teams — ensuring that products spanning consumer health, research tools, and medical devices are developed, commercialized, and sustained to the highest standards of quality, reliability, and regulatory compliance.

Responsibilities

• Leads the ongoing vision and implementation of the Quality Management System (QMS) — spanning consumer, research, and medical device (SaMD) quality, including AI/ML-enabled and generative AI products — in conformance with domestic and international GMP, GCP, GCLP, and GLP regulatory requirements and industry best practices applicable to the portfolio of products and services supported.
• Leads strategic and tactical Quality Planning activities with cross‑functional stakeholders across Verily's medical device, research, and commercial programs, including Software as a Medical Device (SaMD), AI/ML and generative AI applications, consumer health, and medical research contexts, ensuring quality frameworks are fit‑for‑purpose across each domain. Develops and advances quality oversight frameworks for AI/ML and generative AI products, including considerations for model validation, monitoring, algorithmic change protocols, and alignment with emerging regulatory guidance (e.g., FDA's AI/ML‑based SaMD action plan, predetermined change control plans).
• Maintains and advances ISO 13485:2016 certification across Verily's QMS; leads expansion to additional certifications (e.g., MDSAP) as directed by business objectives, in accordance with QA domain responsibilities. Analyzes quality metrics and performance data across consumer, medical research, SaMD, and AI/ML programs to identify trends, drive continuous improvement, and implement effective corrective and preventive actions (CAPA).
• Staffs and develops their QA team with the skills and experience to support quality domains spanning consumer, research, regulated medical device, and AI/ML programs; balances business needs with regulatory compliance. Builds trust, coaches and mentors team members, fosters an inclusive environment, and empowers the team to execute with accountability.
• Fosters a culture of organizational compliance to the QMS through ongoing GxP training, education, and quality awareness initiatives across all product domains, including emerging practices for AI/ML and generative AI governance. Partners with engineering and product teams to embed quality practices into software development workflows; experience with Jira and GitHub (or equivalent tools) is a plus for supporting SaMD and AI/ML quality processes including change control, issue tracking, and Design and Development File management per ISO 13485:2016.

Minimum 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.
• Demonstrated 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.
• Experience supporting or managing quality across SaMD and/or AI/ML‑enabled products, with working knowledge of applicable FDA guidance and international regulatory frameworks.
• Proven ability to lead cross‑functional quality initiatives, manage and develop QA teams, and influence stakeholders across engineering, product, and clinical organizations.

Preferred Qualifications

• Experience with MDSAP audit programs and/or leading successful ISO 13485 certification or surveillance audits.
• Familiarity with emerging regulatory frameworks for AI/ML‑based SaMD, including FDA's predetermined change control plan (PCCP) guidance and international harmonization efforts (e.g., IMDRF).
• Experience supporting quality across GCP and/or GCLP environments, including clinical research or laboratory‑based programs.
• Proficiency with Google Workspace and software development and quality tools such as Jira and GitHub for change control, nonconformance tracking, and design and development file management.
• Advanced degree (MS, MPH, PhD) in a relevant scientific or engineering discipline, or a recognized quality certification such as ASQ CQE, CQA, or RAC.

Qualified applicants must not require employer sponsored work authorization now or in the future for employment in the United States.

The US base salary range for this full‑time position is $142,000 - $213,000 plus bonus, equity, and benefits. Within the range, individual pay is determined by work location and additional factors, including job‑related skills, experience, and relevant education or training.

Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.

Verily Health Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. For our EEO Policy Statement, please click here. If you'd like more information on your EEO rights under the law, please click here.

If you have a need that requires accommodation, please let us know by completing our Accommodations for Applicants form.