GRAIL · 2 days ago
Quality Engineer 2, Device Quality Operations #4376
Durham, NC
Full-time
Onsite
Senior Level
$82K/yr - $96K/yr
5+ years expGRAIL is a healthcare company dedicated to early cancer detection through innovative technologies. The Quality Engineer 2 will be a key contributor in the Quality Operations organization, focusing on executing and improving the quality management system for in vitro diagnostic medical devices.
BiotechnologyHealth CareHealth DiagnosticsMedicalMedical Device
Responsibilities
Support medical device Quality Engineering operations through expert 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, and related regulations and standards
Use proactive, creative problem-solving to contribute to development of concepts and principles to achieve goals and objectives
Demonstrate technical proficiency, creativity, teamwork, collaboration with others, and regular independent thought
Solve extremely complex problems in which analysis of situations or data requires an in-depth evaluation and assessment of intangible variables
Exercise excellent judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results
Act independently to determine methods and procedures to successfully complete assignments
Structure day-to-day work autonomously, effectively communicating status and issues with management
Identify and evaluate deficiencies and improvement opportunities, working cross-functionally to resolve and improve on existing processes
Support qualifications & validation activities (IQ/OQ/PQ/TMV)
Support DHR review process
Support NCR, DAR & CAPA process
Support change management workflows, and acceptance activities including incoming and finished product release
Support Quality Management Review (QMR), Quality Indices metrics generation and review, audits, and on-market Design History File and Risk Management File updates
Support audits and inspections as needed
Support other project teams (including clinical laboratory) as determined by management
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 of experience working within a medical device, pharmaceutical, or biotech quality management system
Experience working with in vitro diagnostic medical device regulations and standards including ISO 13485:2016, 21 CFR 820, IVDR, and other applicable industry requirements
Strong written and verbal communication skills
Ability to comprehend and interpret technical information
Benefits
Annual bonus plan tied to company and individual performance
Incentive plan
Long-term incentive plan to align company and colleague success over time
Flexible time-off
401(k) with a company % match
Medical, dental, and vision insurance plans
Mindfulness offerings
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
2026-01-06
2025-12-01
Company data provided by crunchbase