Senior Supplier Quality Engineer # 4764, #4772

GRAIL•Durham, NC

2d•Hybrid

About The Position

This position is a key individual contributor within the Quality organization, responsible for executing, maintaining, and improving elements of GRAIL’s quality management system (QMS). The primary focus is on supporting GRAIL’s Supplier Quality System for medical device processes. This position interacts with suppliers as well as with departments across the organization, including but not limited to Quality, Procurement, Clinical Laboratory Operations, Technical Operations, Regulatory Affairs, Compliance, Program Management, Clinical Quality Assurance, Supply Chain, Manufacturing, and Research & Development. The person in this role consistently applies critical thinking and sound judgment to solve broad, complex problems, effectively cascading functional strategy and decisions across teams, and communicating status and recommendations to senior management. These roles is based at our Durham, North Carolina, office. 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.

Requirements

Bachelor’s degree in science, engineering, or other technical area.
Minimum of 5 years (corresponding to level) of experience working within a clinical laboratory (high complexity CLIA/CAP environment) or related (e.g., IVD medical device, pharma, etc.) quality management system.
Experience working with applicable regulations and standards including CAP/CLIA, New York State Department of Health, ISO 13485, ISO 15189, and other applicable industry requirements.
Experience supporting regulatory inspections/audits and managing/approving investigations and corrective actions.
Excellent written and verbal communication skills.
Ability to comprehend and interpret technical information.

Nice To Haves

Master’s degree in a related technical area, or MBA a plus.
Next Generation Sequencing (NGS) experience a plus.
ASQ Certified Quality Auditor, Certified Quality Engineer, or similar a plus.

Responsibilities

Leading supplier qualification activities, supporting Quality Management Review (QMR), generating Quality Indices metrics, managing the Quality Planning process, and supporting efforts to obtain and maintain licenses, accreditations, and certifications.
Represents Quality during audits and inspections, as well as on various project teams as determined by management.
Support Quality through interpretation, establishment, and execution of quality engineering concepts and principles, in accordance with GRAIL’s quality management system and regulatory requirements, including ISO 13485, ISO 14971, 21 CFR 820, IVDR, CAP/CLIA/NYSDOH, ISO 15189, and related regulations and standards.
Independently manage activities relating to supplier qualification, performance, audit, changes, and corrective actions.
Use proactive, creative problem-solving to contribute to the development of concepts and principles to achieve goals and objectives, including collaboration with suppliers and internal departments to implement robust Supplier Quality Agreements.
Demonstrate technical proficiency, creativity, teamwork, collaboration, and independent thought.
Exercise good judgment within broadly defined practices and policies when selecting methods, techniques, and evaluation criteria for results.
Act independently with regular oversight to determine methods and procedures to successfully complete assignments.
Structure day-to-day work autonomously, effectively communicating status and issues to management.
Identify and evaluate deficiencies and improvement opportunities, working cross-functionally to resolve and improve existing processes.
Demonstrate increasing technical proficiency by solving progressively complex problems and operating with greater independence.
Conduct supplier audits to ensure ongoing compliance with ISO 13485, ISO 14971, 21 CFR 820, IVDR, CAP/CLIA/NYSDOH, ISO 15189, and other applicable standards and regulations. Actively manage audit findings to completion.
Perform various gap assessments, including CAP/CLIA checklists, to ensure adherence to clinical laboratory requirements and ongoing accreditation needs.
Partner with subject matter experts on various corrective and preventive activities for product and process in addition to supporting other improvement initiatives.
Compile Supplier Quality System trend data and prepare presentations for Quality Management Review meetings.
Support education and training initiatives to strengthen the inspection readiness program at suppliers and throughout GRAIL.
Perform other duties as assigned.