Quality Engineer 2, Quality Operations - Clinical Laboratory # 4790

Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care. We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges. GRAIL is headquartered in the bay area of California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. 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. 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. The expected, full-time, annual base pay scale for this position is $82,000 - $102,000. Actual base pay will consider skills, experience, and location. This role may be eligible for other forms of compensation, including an annual bonus and/or incentives, subject to the terms of the applicable plans and Company discretion. Employees in this role are also eligible for GRAIL’s comprehensive and competitive benefits package, offered in accordance with our applicable plans and policies. This package currently includes flexible time-off or vacation; a 401(k) retirement plan with employer match; medical, dental, and vision coverage; and carefully selected mindfulness programs. GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can thrive, contribute, and grow. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, disability, status as a protected veteran, , or any other class or characteristic protected by applicable federal, state, and local laws. Additionally, GRAIL will consider for employment qualified applicants with arrest and conviction records in a manner consistent with applicable law and provide reasonable accommodations to qualified individuals with disabilities. Please contact us at [email protected] if you require an accommodation to apply for an open position. #J-18808-Ljbffr BioSpace