Quality Systems and Compliance Lead
$142k - $213kVerily Life Sciences
- # Quality Systems and Compliance LeadApplyremote type: Hybridlocations: Dallas, Texas: Boston, Massachusetts: San Bruno, California: Raleigh, North Carolinatime type: Full timeposted on: Posted 2 Days Agojob requisition id: REQ-850# **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.# ****R********esponsibilities***** 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.# **Qualifications**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 + 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 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.### Why Join UsBuild What’s Vital.At Verily, you are a part of something bigger. We are a diverse team of builders innovating at the intersection of health and technology—united by a shared spirit of curiosity, resilience and determination to make better health possible for all. This builder mindset means your fingerprints will be on the work that shapes the future of health.Fulfilling our precision health purpose starts with the health of our Veeps, which is why we offer flexibility, resources, and competitive benefits to support you in your whole-person well being.Our culture reflects the behaviors that stem from living our values every day in how we Innovate Healthcare and Technology, Gain Velocity as One Verily, and Respect Individuals. As One Verily, we uphold our collective accountability to sustain this culture and to create an environment where all Veeps feel included, feel a sense of belonging, and have opportunities to grow.If this sounds exciting to you, we would love to hear from you.
- J-18808-Ljbffr Verily Life Sciences LLC
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Quality Systems and Compliance Lead in Brooklyn, NY vacancy
- Lake Air Products seeks a seasoned Quality Systems Manager to own and improve the QMS across ISO... ...00 and customer requirements. You will lead internal audits, manage CAPA activities... ...culture while ensuring regulatory compliance and continual improvement within a manufacturing...Quality
- Oji Intertech Inc. is seeking a Quality Manager to lead the Quality Management System and drive continual improvement. You will collaborate with process owners and leaders to ensure compliance, quality objectives, and customer satisfaction across the organization. The...Quality
- Chromalloy is seeking a Quality Systems, Audit & Compliance Leader to provide enterprise leadership across quality management systems, internal audit, and regulatory compliance for aerospace manufacturing and repair operations. This role supports FAA Part 145 Repair Station...Quality
- Shawmut Corporation seeks a Quality Assurance Specialist to solidify quality systems and metrics across manufacturing. You will collaborate with internal partners... ...to resolve issues. Responsibilities include leading ISO 9001 audits, guiding production and inspection...Quality
- HellermannTyton is seeking a Quality Technician Supervisor to oversee... ...day-to-day QA activities and lead a technician team on multiple... ...manage escalations, ensure compliance with quality standards, and... ...MES, JDE, and related quality systems. On-site role with a focus on...QualityShift work
- ...CAO), and business information systems Understanding and utilize... ...ensure department appearance, quality, variety, workplace safety, food... ...Food Lion procedures Ensures compliance with local, state and federal... ...preferred Ability to lead and manage a team Strong understanding...QualityLocal areaImmediate start
Food Lion
Brooklyn, NY3 days ago - ...rigorous methodology ensures compliance with domestic and international... ...have been known for our high-quality, custom-built control... .... Job Summary: The Materials Lead is responsible for developing... ...utilization, and material handling systems to support business growth. Drive...QualityWorldwide
Panelmatic
Brooklyn, NY4 days ago - Rolls-Royce plc in Reston, VA is seeking a Capability Lead - Controls Systems to lead and develop the control systems team,... ...automation and the use of digital tools, and ensure compliance with safety, quality, cost, and delivery objectives within Rolls-Royce’s engineering...Quality
- Metalcraft Precision Machining in Elkhart, IN seeks a Quality Manager to build and lead the Quality Management System from the ground up and drive ISO 9001 and AS9100 certification for a growing 20-machine Haas floor. You will inspect parts, generate quality reports, and...QualityDay shift
- Schneider Electric is seeking a Team Lead for Digital Power Systems Quotations in the United States. You will lead and coach Quote Specialists, coordinate workloads, and ensure high-quality, responsive quotations while partnering with Sales and cross-functional teams to...QualityLocal area
- Quantum Sky is seeking an Electronics Security Systems Site Lead Technician to support day-to-day activities for several programs. You will... ...lead, mentor, and coordinate technician teams to deliver high-quality installations from kickoff to close. Required: 5+ years in electronic...QualityRemote job
- PCI Pharma Services is seeking a Quality Systems Specialist II to advance QMS records and drive improvement initiatives across cross-functional teams. You will support deviations, CAPAs, change controls, and audits while ensuring records are complete and compliant. The...Quality
- Description Manage QMS compliance with the appropriate internal and external... ...). Manage Document Control system, including the Change Order... ...Audit Findings processes. Lead supplier management, including... .... Own the development of Quality Metrics, and coordinate quality...Quality
$59k - $98k
...of contact for team questions Quality assurance reviews, feedback,... ...providers Ability to work with other leads to develop policies and... ...job-aides Monitor and ensure compliance with company and client... ...understanding of all software/systems used Identify, validate, and...QualityTemporary workWork at officeFlexible hours- Elbit America is seeking a Quality Specialist I to support the Quality Management System and perform QA activities. The role contributes to product and process... ..., warranty coordination, supplier oversight, and compliance with AS9100/AS9110 and FAA-145 requirements. The...Quality
- Audubon is currently seeking a QC Lead Site Supervisor to join our team... ...work under the direction of the Quality Manager and Director of Quality and Compliance. PRIMARY RESPONSIBILITIES: Implement... ...and Audubon’s Quality Management System. Supervise daily QC inspection...QualityContract workFor subcontractorImmediate start
- Plexus Corp. is seeking a quality professional to help ensure compliance and continual improvement of the Plexus Quality Management Systems at our Neenah, WI site. You will lead and participate in internal and external audits, support CAPA actions, and assist with documentation...Quality
$24.48 - $33.12 per hour
...solutions and services in more than 110 countries and regions. Quality Systems Associate Summary: Under the direct supervision of the... ...perform quality assurance and Training functions to ensure compliance with internal and external regulations and protocol. Primary...QualityHourly payWork at officeFlexible hoursGrifols, S.A
Brooklyn, NY2 days ago$158k - $184k
Washington, D.C. Backed by leading Silicon Valley investors, Peregrine... ...building the security and compliance capabilities necessary to... ...environments, and agency-specific system authorizations. This is not a... ...improve the efficiency and quality of Peregrine's assurance program...QualityContract workFor contractorsFor subcontractorWork at officeLocal areaRelocationVisa sponsorship- Abbott is seeking a Staff Systems Integration Specialist for our Diagnostics/Core Lab. The... ...software, assays, and labeling. You will lead risk assessments, develop test methods, mentor... ...data-driven improvements aligned with quality and regulatory requirements. #J-18808-...Quality
- Quanta Consultancy Services Ltd. is seeking a System Owner Purification for an Ohio-based, 12-month project focused on commissioning... ...requirements. The candidate will support the Construction Quality Lead, review field changes and as-built updates, and monitor installation...Quality
- ...seeking a Telecom Aerial Foreman to oversee installation, maintenance, and repair of aerial telecom systems on-site, ensuring safety, quality, and regulatory compliance. You will guide and support less experienced team members and serve as the on-site expert. The role...Quality
- The Supply Technician Lead is the Subject Matter Expert in support... ...site. This role ensures compliance with U.S. Army supply regulations... ...records in Army logistics systems. The Supply Technician is directly... ...Coordinate with supervisors, Quality Assurance staff, and...QualityContract workFor contractorsWork at officeRemote work
- ...accurate, complete documentation and Medicare compliance. You’ll collaborate with clinicians,... ...requirements, and contribute to high-quality patient care in home health settings. Strong... ...OASIS, documentation standards, and EHR systems is required, with emphasis on detail and...QualityWork at office
$116k - $182.27k
Job Description Job Title: Lead Clinical Study Manager (LeadCSM) BU/Organization:... ...program(s) to meet study objectives in compliance with quality standards (including ICH GCP, local regulations... ...timely updates of budget and financial system(s) are accurate. Communicates study...QualityMinimum wageFull timeContract workTemporary workLocal areaRemote workFlexible hoursNight shift$20 per hour
...features some of the highest quality, most awarded and most popular... ...we aim to revolutionize and lead the nation’s cannabis industry... ...with a focus on regulatory compliance, product consistency, and customer... ...processing, point-of-sale systems, windows-based software,and...QualityPermanent employmentFull timePart timeLocal areaMonday to Friday$20 per hour
...features some of the highest quality, most awarded and most popular... ...we aim to revolutionize and lead the nation’s cannabis industry... ...with a focus on regulatory compliance, product consistency, and customer... ...processing, point-of-sale systems, windows-based software, and...QualityPermanent employmentFull timePart timeLocal areaMonday to Friday- ...supervision, budgeting, and external partnerships to ensure high-quality services in compliance with grants and agency standards. Responsibilities... ...daily operations, staff development, shelter emergency systems, and pursuing funding opportunities while maintaining program...QualityPermanent employment
- ...& Analytics team is seeking a high-impact Financial Reporting Systems Lead with deep technical capability and an advanced finance/MIS domain... ...recommendations.Establish foundational controls and data quality practices, including reconciliations, auditability, and robust...QualityVisa sponsorship
- ...patient intake and satisfaction. The role directs day-to-day clinical and administrative activities, supervises office procedures, and collaborates with vendors and affiliates to deliver compliant, high-quality care. #J-18808-Ljbffr Temple University Health System, Inc.QualityWork at office
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Quality Systems and Compliance Lead. Be the first to apply!
Related searches
- quality management nurse Brooklyn, NY
- quality reviewer Brooklyn, NY
- quality evaluator Brooklyn, NY
- supplier quality Brooklyn, NY
- quality improvement nurse Brooklyn, NY
- water quality Brooklyn, NY
- quality equipment Brooklyn, NY
- quality assurance quality control engineer Brooklyn, NY
- quality intern Brooklyn, NY
- quality inspection Brooklyn, NY