Senior Quality Engineer - Quality Strategy & Operational Excellence # 4408

GRAIL; Durham (NC); On-site; USD 91,000 - 121,000; Full time

Job summary

A pioneering healthcare company in Durham, NC, seeks a Senior Quality Engineer to improve Quality Management System processes related to cancer detection. Candidates must have extensive experience in QMS within medical devices or pharmaceuticals, with solid problem-solving and analytical skills. The role offers a salary range of $91,000 - $121,000, flexible time-off, and a benefit package including 401k matching and wellness offerings.

Benefits

Flexible time-off

401k with company match

Medical, dental, vision plans

Qualifications

• 8+ years of related experience working within a medical device, pharmaceutical, or biotech QMS.
• Demonstrated knowledge of regulations like ISO 13485 and QSR.
• Experience supporting regulatory inspections/audits.

Responsibilities

• Facilitate and coordinate the CAPA program and NCR program.
• Lead nonconformance report meetings to ensure compliance.
• Provide guidance as a subject matter expert on applicable regulations.

Skills

Analytical thinking

Communication skills

Problem-solving

Teamwork

Education

Bachelor’s degree in science, engineering or other technical area

Tools

Smartsheet

Veeva Vault

Google Docs

Google Slides

Job description

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.

Reporting to the Senior Director, Quality Strategy & Operational Excellence, the Senior Quality Engineer is responsible for executing, maintaining, and improving key Quality Management System (QMS) processes including Corrective and Preventive Action (CAPA) investigations, Nonconformance (NCR) reporting, Quality Management Review (QMR), clinical laboratory Quality Monitoring and Improvement (QMI), and Quality Indices (QI). This role also supports Change Control, Quality Planning, clinical laboratory licensure/certification, internal and external audits, and other activities as assigned. This person will work cross‑functionally to ensure alignment and implementation of QMS programs while adhering to strict project and program timelines and deliverables. The person in this role consistently applies critical thinking skills and good judgment to solve complex problems, effectively communicating status and recommendations to management.

The person in this role must be able to work on‑site from GRAIL’s Durham, NC facility approximately 3 days a week.

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 Quality Management System procedures and regulatory requirements including ISO 13485, ISO 14971, 21 CFR 820, IVDR, CAP/CLIA/NYSDOH, ISO 15189, and related regulations and standards.
• Lead regularly scheduled meetings to ensure timely and compliant completion of Nonconformance reports (NCRs), obtaining and communicating status and escalating effectively as needed to obtain executive awareness and support.
• Coordinate the CAPA Review Board, ensuring timely and compliant completion of CAPAs, obtaining and communicating status and escalating effectively as needed to obtain executive awareness and support.
• Coordinate generation and analysis of monthly Quality Indices reports (quality metrics) as part of Measurement, Analysis, and Improvement activities, rolling up into medical device QMR and clinical laboratory QMI meetings.
• Facilitate quality planning activities including optimizing planning tools, workflows, and documentation, and obtaining and communicating status, escalating effectively as needed to obtain executive awareness and support.
• Respond to process and software system‑related inquiries and maintain effective cross‑functional team communications to advance GRAIL’s quality activities and promote compliant and standard process execution.
• Maintain, improve, and facilitate training and competency programs for the CAPA and NCR processes.
• Lead software system configuration maintenance and improvements, including testing and validation, updating documents (SOPs, reports, protocols, specifications, etc.), as well as documenting, assessing, and resolving feedback to improve the end user experience.
• Cultivate positive relationships with cross‑functional partners, leadership team members, and personnel executing and supporting these processes.
• Assess unusual circumstances and use sophisticated analytical and problem‑solving techniques to identify causes. Proactively resolve a wide range of issues in creative and compliant ways.
• Demonstrate technical proficiency, creativity, teamwork, collaboration with others, and regular independent thought.
• Exercise good judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining 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 with management.
• Participate in preparation for and execution of internal and external audits and inspections.
• Support timely and compliant responses to observations.
• Provide guidance to other departments and serve as subject matter expert (SME) on applicable regulations and standards.
• Perform other duties as assigned by management.

Qualifications:

• Bachelor’s degree in science, engineering, or other technical area. 8+ years of related experience (Masters 5+ years) working within a medical device, pharmaceutical, or biotech QMS, with expertise in CAPA, NCR, and metrics reporting.
• Demonstrated knowledge and understanding of applicable regulations and standards, including but not limited to QSR, ISO 13485, CAP/CLIA, NYSDOH, ISO 15189, IVDR.
• Experience using an eQMS required; Veeva Vault preferred.
• Proven ability to efficiently manage workload under tight deadlines and pressure in a composed manner.
• Demonstrated ability to perform meticulous work with a high degree of accuracy and completeness.
• Experience supporting regulatory inspections/audits and responding to findings.
• Excellent written and verbal communication skills.
• Expertise managing data reporting and communications using tools including Smartsheet, Confluence, Google Docs and Google Slides.
• ASQ Certified Quality Auditor, Certified Quality Engineer, or similar.

Expected full time annual base pay scale for this position is $91,000 - $121,000. 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 at [e-mail] to request accommodation. GRAIL maintains a drug‑free workplace.