Quality Engineer 2, Quality Operations - Clinical Laboratory # 4790

About the role

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).

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).
• Lead and contribute to achieve company goals in creative and effective ways.
• Solve moderate problems in which analysis of situations or data requires an in-depth evaluation and assessment of intangible variables.
• 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.
• Facilitate Quality Operations-related training, coaching, mentoring and guidance to Clinical Laboratory personnel as well as cross-functional teams.

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).