GRAIL
Healthcare
QualityEngineer2,QualityOperations-ClinicalLaboratory
Neural analysis suggests this role is
optimal for Mid candidates.
“Quality Engineer 2, Quality Operations - Clinical Laboratory at GRAIL. Skills: quality engineering, root cause analysis, CAPA, data-driven problem solving, regulatory compliance. Leads engineering analyses of inspection and production data to assess product performance, identify quality issues, and recommend actions. Conducts quality investigations, including root cause analysis, documentation, and assisting in the development and implementation of corrective and preventive actions”
What You'll Achieve.
assess product performance; identify quality issues; recommend actions; ensure inspection activities and product evaluations align with specifications, drawings, and quality expectations; support audits, internal reviews, and ongoing compliance with company methods and regulatory requirements; contributing to organizational regulatory compliance
Industry & Context.
data-driven problem solving; root cause analysis; quality investigations; troubleshooting
Work is performed in office, laboratory, and manufacturing environments, Regular interaction with production floor operations for quality reviews and troubleshooting, Use of precision measurement and inspection equipment as needed, Potential exposure to manufacturing noise, equipment, and regulated materials, PPE required when performing inspections or working in controlled environments, Standard business schedule with occasional overtime or travel to supplier sites or customer locations, drug-free workplace
What They're Looking For.
Must Have
Bachelor’s degree in Engineering, Quality, Manufacturing, or related technical discipline, 2–5 years of relevant quality, manufacturing, or engineering experience, Demonstrated level of knowledge regarding applicable regulatory standards commensurate with the position's complexity and scope, Solid knowledge of quality engineering principles, standards, and regulatory requirements, Proficiency in root cause analysis, CAPA, and data-driven problem solving, Ability to interpret engineering drawings, specifications, and GD&T, Familiarity with quality management systems (QMS) and regulatory compliance frameworks (ISO, GMP, FDA, etc.), communication and technical writing skills
Nice to Have
Master’s degree with 0–2 years of experience, Effective project and time management abilities, Skilled in the use of statistical analysis and quality tools (SPC, Minitab, or similar), Ability to work independently and collaboratively in a team environment
What You'll Do.
Leads engineering analyses of inspection and production data to assess product performance
identify quality issues
and recommend actions
Conducts quality investigations
including root cause analysis
and assisting in the development and implementation of corrective and preventive actions
Develops or updates qualification and inspection criteria
Collaborates with technicians and cross-functional partners to ensure inspection activities and product evaluations align with specifications
and quality expectations
Evaluates nonconforming materials by reviewing defect information
assessing potential impact
and coordinating disposition activities
Responsible for supplier quality activities by reviewing incoming inspection results
and supporting supplier corrective action processes
Prepares technical reports
and quality records to support audits
and ongoing compliance
Makes decisions for quality planning and continuous improvement efforts by identifying trends
providing input on process enhancements
and applying quality tools and analytical methods
May participate in internal
external or supplier audit activities
How You'll Work.
Team & Collaboration
Collaborates with technicians and cross-functional partners; Ability to work collaboratively in a team environment
Communication Scope
communication skills; technical writing skills
Process & Methodology
Effective project and time management abilities
Full Job Description
## 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 the bay area of 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 ## Responsibilities Leads engineering analyses of inspection and production data to assess product performance, identify quality issues, and recommend actions within defined procedures. Conducts quality investigations, including root cause analysis, documentation, and assisting in the development and implementation of corrective and preventive actions. Develops or updates qualification and inspection criteria, quality procedures, and documentation in alignment with established quality assurance standards and engineering requirements. Collaborates with technicians and cross-functional partners to ensure inspection activities and product evaluations align with specifications, drawings, and quality expectations. Evaluates nonconforming materials by reviewing defect information, assessing potential impact, and coordinating disposition activities with quality or engineering personnel. Responsible for supplier quality activities by reviewing incoming inspection results, documenting issues, and supporting supplier corrective action processes. Prepares technical reports, dat
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