Quality Systems and Compliance Lead

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.

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.

• 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 Verilys 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. FDAs AI/ML-based SaMD action plan predetermined change control plans).

• Maintains and advances ISO 13485:2016 certification across Verilys 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

• Bachelors 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 FDAs 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 $142000 - $213000 bonus equity benefits. Our salary ranges are determined by role level and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. Within the range individual pay is determined by work location and additional factors including job-related skills experience and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

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 youd 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.