Quality Engineer 2, Quality Operations - Clinical Laboratory # 4790

The Quality Product Engineer 2 contributes to ensuring products, components, and materials meet established quality standards and regulatory requirements by performing engineering analyses, supporting quality investigations, and developing elements of quality plans, qualification and inspection criteria. This role applies foundational engineering knowledge with growing independence, supporting operations, evaluating nonconformances, and collaborating with cross-functional teams to maintain effective quality processes aligned with defined quality assurance methods and organizational standards.

This role is based at our Durham, North Carolina, office and offers a flexible working arrangement. It offers a flexible work arrangement, with the ability to work from GRAIL's office or from home. Our current flexible work arrangement policy requires that a minimum of 60%, or 24 hours, of your total work week be on-site. Your specific schedule, determined in collaboration with your manager, will align with team and business needs and could exceed the 60% requirement for the site.

• 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.

• 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.

• 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.

 

• 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.