This role involves maintaining and improving GRAIL's quality management system, facilitating audits, compliance with regulations, and driving quality performance.
Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care.
We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.
GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies.
For more information, please visit grail.com.
This position is a key individual contributor within the Quality organization, responsible for executing, maintaining, and improving elements of GRAIL’s quality management system (QMS). The primary focus is on supporting GRAIL’s Quality Management System for medical device processes, with consideration for the unified GRAIL quality management system. This position interacts with departments across the organization, including but not limited to Quality, Clinical Laboratory Operations, Technical Operations, Regulatory Affairs, Compliance, Program Management, Clinical Quality Assurance, Supply Chain, Manufacturing, and Research & Development. The person in this role consistently applies critical thinking and sound judgment to solve broad, complex problems, effectively cascading functional strategy and decisions across teams, and communicating status and recommendations to senior management.Primary responsibilities include leading and conducting Internal Audits, supporting Quality Management Review (QMR), generating Quality Indices metrics, evolving standards watch and management, managing the Quality Planning process, and supporting efforts to obtain and maintain licenses, accreditations, and certifications.This individual contributes to a positive environment of accountability and performance excellence. The Sr. Quality Engineer represents Quality during audits and inspections, as well as on various project teams as determined by management. The ideal candidate will demonstrate the ability to lead and drive improvements within a work culture committed to GRAIL values.This position requires regular on-site presence, at the discretion of management.
Responsibilities:
- Support Quality through interpretation, establishment, and execution of quality engineering concepts and principles, in accordance with GRAIL’s quality management system and regulatory requirements, including ISO 13485, ISO 14971, 21 CFR 820, IVDR, CAP/CLIA/NYSDOH, ISO 15189, and related regulations and standards.
- Use proactive, creative problem-solving to contribute to the development of concepts and principles to achieve goals and objectives.
- Demonstrate technical proficiency, creativity, teamwork, collaboration, and independent thought.
- Exercise good judgment within broadly defined practices and policies when selecting methods, techniques, and evaluation criteria for results.
- Act independently with regular oversight to determine methods and procedures to successfully complete assignments.
- Structure day-to-day work autonomously, effectively communicating status and issues to management.
- Identify and evaluate deficiencies and improvement opportunities, working cross-functionally to resolve and improve existing processes.
- Demonstrate increasing technical proficiency by solving progressively complex problems and operating with greater independence.
- Implement and manage GRAIL’s Standards Watch program (e.g., BSI Compliance Navigator, CLSI, ANSI), including the analysis, administration, and maintenance of internal standards libraries. This includes managing user accounts and access in Compliance Navigator and related systems, as well as ensuring timely updates to reflect evolving industry standards.
- Conduct internal audits to ensure ongoing compliance with ISO 13485, ISO 14971, 21 CFR 820, IVDR, CAP/CLIA/NYSDOH, ISO 15189, and other applicable standards and regulations. Actively manage audit findings to completion.
- Manage and execute CAPA workflow.
- Perform various gap assessments, including CAP/CLIA checklists, to ensure adherence to clinical laboratory requirements and ongoing accreditation needs.
- Manage the quality planning process, including tracking status, reviewing progress of individual owners, and reporting on key metrics.
- Oversee the maintenance and renewal of licenses and certificates, including ISO certifications and clinical laboratory licenses, ensuring all licenses and certifications are current and in good standing.
- Compile Quality System trend data and prepare presentations for Quality Management Review meetings.
- Support education and training initiatives to strengthen the inspection readiness program throughout GRAIL.
- Perform other duties as assigned.
Preferred Qualifications
- Bachelor’s degree in science, engineering, or other technical area.
- Master’s degree in a related technical area, or MBA preferred.
- Minimum of 5 years (corresponding to level) of experience working within a clinical laboratory (high complexity CLIA/CAP environment) or related (e.g., IVD medical device, pharma, etc.) quality management system.
- Experience working with applicable regulations and standards including CAP/CLIA, New York State Department of Health, ISO 13485, ISO 15189, and other applicable industry requirements.
- Experience supporting regulatory inspections/audits and responding to findings.
- Excellent written and verbal communication skills.
- Ability to comprehend and interpret technical information.
- Next Generation Sequencing (NGS) experience preferred
- ASQ Certified Quality Auditor, Certified Quality Engineer, or similar preferred
- CAP experience preferred.
The expected, full-time, annual base pay scale for this position is $91K - $114K for Durham, NC. Actual base pay will consider skills, experience, and location.
Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time.
In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings.
GRAIL is an Equal Employment Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. GRAIL maintains a drug-free workplace.
Top Skills
21 Cfr 820
Cap/Clia
Iso 13485
Iso 14971
Iso 15189
Ivdr
Next Generation Sequencing (Ngs)
Nysdoh
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