GRAIL · 7 hours ago
Quality Audit Specialist # 4572
Durham, NC
Full-time
Hybrid
Mid Level
$94K/yr - $118K/yr
3+ years expGRAIL is a healthcare company pioneering new technologies for early cancer detection. The Quality Audit Specialist is responsible for supporting the development and maintenance of the internal audit program and ensuring compliance with regulatory standards.
BiotechnologyHealth CareHealth DiagnosticsMedicalMedical Device
Responsibilities
Responsible for creating annual internal audit schedules, developing internal audit plans and coordinating activities with cross-functional teams
Function as a lead auditor for internal audits and perform audits to ensure compliance to procedures and regulatory standards by examining and analyzing records, reports, procedures and related documentation; Provide recommendations for continuous improvement to strengthen the internal processes and structure
Responsible for documenting audit findings and monitoring corrective actions associated with the audit findings until closure
Responsible for developing and maintaining policies and procedures for an effective and compliant internal audit program. Develop, prepare and maintain various QMS metrics and dashboards for management review and quality monitoring
Manage and lead the lifecycle requirements for the electronic QMS
Assist with QMS activities, such as CAPAs, non-conformance, deviations, supplier quality, complaints, process monitoring and improvement, and batch records review
Provide training, guidance, and support to the company for QMS related policies and procedures
Develop solutions to routine assigned activities of moderate scope and complexity
Independently determine and develop an approach to solutions for moderate/complex problems
Provide continuous assessment and identify areas of improvement for the QMS
Lead process improvement projects of low/medium complexity
Other duties as assigned
Qualification
Required
BA/BS (or equivalent industry experience) with 3 + years of experience in the life sciences industry, preferably in an FDA medical device/IVD regulated environment
Strong working knowledge of FDA QSR/cGMP and ISO 13485, ISO 14971 regulations
Must have good verbal, written, communication and organizational skills, and be able to work in a cross-functional team environment
Ability to perform a variety of duties involving critical thinking, analysis, evaluation, and judgment in support of QMS activities
Ability to work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors
Ability to prioritize tasks and deliver assignments with high quality in a timely manner
Preferred
ISO 13485 auditor preferred
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
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
The Motley Fool
2026-01-23
2026-01-16
2026-01-14
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