Quality Engineer 2, Quality Operations - Clinical Laboratory # 4790

This position is a key individual contributor in the Quality Operations organization, responsible for executing, maintaining, and improving the clinical laboratory Quality Operations elements of GRAIL's quality management system (QMS). This role's focus is on GRAIL's clinical laboratories, supporting the medical device processes as needed with consideration for the single GRAIL quality management system. This position interacts with departments throughout the organization including but not limited to all-Quality, Clinical Laboratory Operations, Technical Operations, Regulatory Affairs, Compliance, Program Management, Clinical Affairs, Supply Chain, Manufacturing, and Research & Development. The person in this role consistently applies critical thinking skills and good judgment to solve problems of moderate scope, which are often varied and routine where analysis of situations or data requires a review of a variety of factors, effectively cascading decisions across teams and communicating status and recommendations to management. 

Primary responsibilities include supporting the clinical laboratory alternative performance assessment (APA) program, equipment program, CAP checklists, supporting completion of clinical laboratory Quality Indices reports, Quality Monitoring and Improvement (QMI) meetings, and executing and facilitating clinical laboratory quality workflows including NCRs, planned deviations, CAPAs, validations, complaints, risk management records, change management and document change controls. This individual contributes to a positive environment of accountability and performance excellence. This individual represents Quality Operations during audits and inspections as well as on various project teams as determined by management.

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.

Responsibilities:

Support clinical laboratory quality operations through competent interpretation and execution of quality engineering principles and concepts in accordance with GRAIL's quality management system and regulatory requirements including ISO 15189, 21 CFR Part 493 (CLIA), CAP, and New York State Department of Health (NYSDOH). 

Leads and contributes to achieve  company goals in creative and effective ways.

Demonstrate technical proficiency, creativity, teamwork, collaboration with others, and regular independent thought. 

Solve moderate problems in which analysis of situations or data requires an in-depth evaluation and assessment of intangible variables. 

Exercise independent judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results. 

Structure day-to-day work autonomously, effectively communicating status and issues with management. 

Convey  advanced information and persuade several diverse stakeholders/audiences. 

Identify and evaluate deficiencies and improvement opportunities, working cross-functionally to resolve and improve on existing processes. 

Demonstration of increasing technical proficiency; solving moderate problems, with a level of independence in day to day activities. 

Facilitate proficiency testing program/alternative performance assessment program and licensures. 

Facilitate equipment comparability program and CAP checklist completions. 

Support monthly Quality Indices reports and quarterly Quality Monitoring and Improvement (QMI) Reviews. 

Perform risk assessments and work with leadership to create action plans to mitigate laboratory risks. 

Facilitate timely and effective clinical lab-related NCRS, CAPAS, planned deviations, validations, complaints, and change control workflows. 

Serve as SME for clinical laboratory audits and inspections. 

Support maintenance and improvement of the QMS, including ensuring the system is efficient and compliant, through identification and monitoring of key performance indicators. Use professional concepts in accordance with company objectives to solve complex problems in creative and effective ways. 

Facilitates Quality Operations-related training, coaching, mentoring and guidance to Clinical Laboratory personnel as well as cross-functional teams. 

Other duties as assigned. 

These responsibilities summarize the role’s primary responsibilities and are not an exhaustive list. They may change at the company’s discretion. 

Required Qualifications:

• BS/BA degree with 3 years of related experience, or Masters with 1 year of related experience, or PhD  with related experience within a clinical laboratory (high complexity CLIA/CAP environment) or related (e.g., IVD medical device, pharma, etc.) quality management system.

• Experience working with or working knowledge of applicable regulations and standards including CAP/CLIA, New York State Department of Health, ISO 15189, and other applicable industry requirements. 

• Excellent written and verbal communication skills. 

• Ability to comprehend and interpret technical information related to analytical methods, processes, and regulatory requirements. 

Preferred Qualifications:

Master's degree in a related technical area, or MBA. 

Next Generation Sequencing (NGS) experience. 

ASQ Certified Quality Auditor, Certified Quality Engineer, or similar. 

In vitro diagnostic medical device QMS experience (ISO 13485:2016, 21 CFR 820, In Vitro Diagnostic Regulation).

Physical Demands and Work 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.