GRAIL

Healthcare

QualityEngineer2,QualityOperationsClinicalLaboratory

Durham, North Carolina, United States FULL TIME Remote Friendly
The Brief

“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.

Healthcare
Problems you'll solve

data-driven problem solving; root cause analysis; quality investigations; troubleshooting

Eligibility Requirements

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

Free ATS check

Applying for this Quality Engineer 2, Quality Operations - Clinical Laboratory role?

Most applicants get filtered before a human reads their resume. See if yours makes the cut.

How to Apply on Lever

  • Lever uses a streamlined one-page form — apply in under 5 minutes.
  • LinkedIn import works well; review parsed data before submitting.
  • The cover letter field is optional but visible to reviewers — use it to differentiate.
  • Referral codes from employees can significantly boost visibility of your application.

ANONYMOUS · UNFILTERED

What do employees actually say about GRAIL?

Real rants from real employees. Read before you apply.

Read Company Rants →