Hybrid Staff Quality Engineer, CAPA Program

at GRAIL

• Job title: Staff Quality Engineer, CAPA Program
• Job type: Full Time
• Experience level: Lead
• Salary: $118,000 - $147,000 per year
• Degree requirement: Bachelor's Degree
• Tech skills: Google Cloud Platform
• Location requirements: Hybrid, Durham, United States

About the role

• Staff Quality Process Engineer for GRAIL working on quality engineering projects and compliance. Leading initiatives for early cancer detection technologies in North Carolina.

Responsibilities

• Lead and execute high-impact quality engineering projects that improve product quality, reliability, and compliance.
• Develop, implement, and maintain advanced quality control processes, statistical methods, and risk management practices.
• Lead complex root cause investigations and corrective/preventive action plans, ensuring systemic issues are addressed.
• Partner with engineering, manufacturing, and supply chain teams to design and optimize processes for quality and efficiency.
• Provide technical expertise in measurement system analysis, process validation, and statistical process control.
• Serve as a subject matter expert during internal audits, regulatory inspections, and customer quality assessments.
• Prepare and present quality metrics, trend analyses, and recommendations to senior leadership.
• Mentor and coach junior and mid-level engineers, promoting knowledge sharing and development across the team.

Requirements

• Bachelor's degree in Engineering, Quality Assurance, Industrial Technology, or a related field with 8–12 years of relevant work experience in quality engineering, process engineering, or manufacturing; OR Master's degree with 5–8 years of relevant experience; OR PhD with 2–5 years of relevant experience.
• Demonstrated level of knowledge regarding applicable regulatory standards commensurate with the position's complexity and scope, contributing to organizational regulatory compliance. Minimal applicable standards for this position include:
• GMP quality management systems (e.g. ISO 13485)
• Risk assessment frameworks (e.g. ISO 14971)
• Clinical laboratory regulations (e.g. CAP, CLIA, NYSDOH, ISO 15189)
• Operations within the regulated medical device environment (e.g. IVDD, IVDR, FDA 21 CFR 800 series, FDA 21 CFR Part 11)
• Development and Operations within a regulated clinical study environment (e.g. ICH E6 (GCP), ISO 20916, FDA 21 CFR Part 11, Part 50, Part 54, Part 56)

Benefits

• flexible time-off or vacation
• 401(k) retirement plan with employer match
• medical, dental, and vision coverage
• carefully selected mindfulness programs