Quality Engineer 2, Quality Operations

GRAIL

Quality Engineer ensuring product quality and regulatory compliance for innovative early cancer detection technologies at GRAIL. Working collaboratively on quality assurance processes in the clinical laboratory domain.

Posted 5/13/2026full-timeDurham • North Carolina • 🇺🇸 United StatesJuniorMid-LevelWebsite

About the role

Key responsibilities & impact

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, data summaries, and quality records to support audits, internal reviews, and ongoing compliance with company methods and regulatory requirements.
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.
These responsibilities summarize the role’s primary responsibilities and are not an exhaustive list. They may change at the company’s discretion.

Requirements

What you’ll need

Bachelor’s degree in Engineering, Quality, Manufacturing, or related technical discipline.
2–5 years of relevant quality, manufacturing, or engineering experience; Master’s degree with 0–2 years of experience acceptable.
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)
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.).
Strong communication and technical writing skills.

Benefits

Comp & perks

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

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

root cause analysisCAPAdata-driven problem solvingquality engineering principlesquality management systemsregulatory compliance frameworksGMP quality management systemsrisk assessment frameworksclinical laboratory regulationsinterpret engineering drawings

Soft Skills

strong communication skillstechnical writing skills

Certifications

Bachelor’s degree in EngineeringMaster’s degree in Engineering