GRAIL · 17 hours ago
Senior Quality Process Engineer #4346
California, United States
Full-time
Hybrid
Senior Level
$91K/yr - $114K/yr
5+ years expGRAIL is a healthcare company pioneering new technologies to advance early cancer detection. The Senior Quality Process Engineer will be responsible for executing, maintaining, and improving elements of GRAIL’s quality management system, with a focus on medical device processes and collaboration across various departments.
BiotechnologyHealth CareHealth DiagnosticsMedicalMedical Device
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
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
Perform various gap assessments, including CAP/CLIA checklists, to ensure adherence to clinical laboratory requirements and ongoing accreditation needs
Partner with subject matter experts on various corrective and preventive activities for product and process in addition to supporting other improvement initiatives
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
These responsibilities summarize the role’s primary responsibilities and are not an exhaustive list. They may change at the company’s discretion
Qualification
Required
Bachelor's degree in science, engineering, or other technical area
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
Preferred
Master's degree in a related technical area, or MBA a plus
Next Generation Sequencing (NGS) experience a plus
ASQ Certified Quality Auditor, Certified Quality Engineer, or similar a plus
Benefits
Flexible time-off or vacation
A 401(k) retirement plan with employer match
Medical, dental, and vision coverage
Carefully selected mindfulness programs
Company
GRAIL
Grail is a healthcare company that develops pan-cancer screening tests designed to detect cancers at an early stage.
1001-5000 employees
H1B Sponsorship
GRAIL has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (21)
2024 (26)
2023 (23)
2022 (46)
2021 (25)
2020 (9)
Funding
Current Stage
Public CompanyTotal Funding
$2.44BKey Investors
ARCH Venture PartnersIllumina
2025-10-20Post Ipo Equity· $325M
2025-10-16Post Ipo Equity· $110M
2024-06-13IPO
Leadership Team
Satnam Alag
Senior Vice President Software Engineering and Chief Security Officer
Joshua J. Ofman
President
Recent News
2026-01-16
2026-01-14
2026-01-13
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