Senior Quality Engineer - Quality Strategy & Operational Excellence # 4408 at GRAIL

Durham, North Carolina, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, BiotechnologyIndustries

Requirements

Ability to work on-site from GRAIL’s Durham, NC facility approximately 3 days a week
Experience with Quality Management System (QMS) processes including CAPA investigations, NCR reporting, QMR, QMI, and Quality Indices
Knowledge of regulatory requirements including ISO 13485, ISO 14971, 21 CFR 820, IVDR, CAP/CLIA/NYSDOH, ISO 15189, and related standards
Strong critical thinking skills and good judgment to solve complex problems
Effective communication skills to report status and recommendations to management
Ability to work cross-functionally to ensure alignment and implementation of QMS programs while adhering to strict project timelines and deliverables

Responsibilities

Facilitate and coordinate the CAPA program, NCR program, quality metrics, and quality planning process
Maintain and improve these programs in compliance with GRAIL’s QMS procedures and regulatory requirements
Lead regularly scheduled meetings to ensure timely and compliant completion of NCRs, obtaining and communicating status, and escalating as needed
Coordinate the CAPA Review Board, ensuring timely and compliant completion of CAPAs, obtaining and communicating status, and escalating as needed
Coordinate generation and analysis of monthly Quality Indices reports as part of Measurement, Analysis, and Improvement activities for QMR and QMI meetings
Facilitate quality planning activities including optimizing planning tools, workflows, and documentation, obtaining and communicating status, and escalating as needed
Respond to process and software system-related inquiries and maintain effective cross-functional team communications
Maintain, improve, and facilitate training and competency programs for CAPA and NCR processes
Lead software system configuration maintenance and improvements, including testing, validation, document updates, and resolving feedback
Cultivate positive relationships with cross-functional partners, leadership, and personnel
Assess unusual circumstances and use sophisticated analysis (incomplete in description)

Skills

Key technologies and capabilities for this role

Quality Management SystemCAPANCRQMRQMIQuality IndicesChange ControlQuality PlanningAuditsCritical Thinking

Questions & Answers

Common questions about this position

Is this a remote position or does it require on-site work?

The role requires working on-site from GRAIL’s Durham, NC facility approximately 3 days a week.

What salary or compensation is offered for this Senior Quality Engineer role?

This information is not specified in the job description.

What key skills and experience are required for this position?

The role requires experience with Quality Management System processes including CAPA investigations, NCR reporting, QMR, QMI, and Quality Indices, along with knowledge of regulations like ISO 13485, ISO 14971, 21 CFR 820, IVDR, CAP/CLIA/NYSDOH, and ISO 15189. Critical thinking skills and good judgment to solve complex problems, plus effective communication with management, are essential.

What is the team structure or reporting line for this role?

The position reports to the Senior Director, Quality Strategy & Operational Excellence, and involves cross-functional work to ensure alignment and implementation of QMS programs.

What makes a strong candidate for this Senior Quality Engineer position?

Strong candidates will have expertise in facilitating CAPA and NCR programs, coordinating review boards and quality metrics, maintaining compliance with key regulations like ISO 13485 and 21 CFR 820, and demonstrating critical thinking, problem-solving, and communication skills.

GRAIL

Develops blood tests for early cancer detection

About GRAIL

GRAIL focuses on improving cancer detection through advanced blood tests that identify cancer at its earliest stages, enhancing treatment success rates. The company utilizes high-intensity sequencing to analyze tumor genome data, employing algorithms and deep learning to extract actionable information for early cancer detection. GRAIL differentiates itself from competitors by its commitment to large-scale clinical studies that validate the effectiveness of its tests. The primary goal is to reduce global cancer mortality by enabling early diagnosis, making the disease more treatable.

Menlo Park, CaliforniaHeadquarters

2016Year Founded

$1,765.5MTotal Funding

ACQUISITIONCompany Stage

Biotechnology, HealthcareIndustries

1,001-5,000Employees

Benefits

Outstanding People - Join a team of passionate and dedicated professionals, committed to collaboration, education, and proactive problem-solving.

Strong Compensation - We offer competitive salaries and savings plans to provide for long-term financial planning.

Complete Health Coverage - Take advantage of comprehensive health coverage, with medical, dental and vision, to keep you and your family healthy.

Work-Life Balance - Make everyday life more manageable with flexible time off – we trust you to do great work and take time for yourself.

Risks

Potential overdiagnosis could impact the perceived value of GRAIL's tests.

Significant net losses may affect investor confidence and long-term sustainability.

High test costs may limit accessibility in markets with less healthcare funding.

Differentiation

GRAIL uses high-intensity sequencing for early cancer detection via blood tests.

The Galleri test screens for over 50 cancers with a single blood draw.

GRAIL's tests are supported by large-scale clinical studies ensuring reliability.

Upsides

Collaborations with platforms like Function Health expand Galleri test accessibility.

Revenue from Galleri grew 52% year-over-year, indicating strong market demand.

GRAIL's technology aligns with trends in personalized and preventative medicine.

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