Staff Quality Engineer, CAPA Program #4693

Team: Quality & Clinical Compliance

Location: Durham, NC

Commitment: Full-Time

Workplace Type: hybrid

Responsibilities:

• Lead GRAIL’s CAPA program within the Quality Management System (QMS), including planning and running CAPA Review Board meetings, overseeing program and individual CAPA activities to ensure on-time and compliant execution, and delivering effective training to CAPA Owners and stakeholders.
• Maintain and improve the CAPA program in compliance with GRAIL’s Quality Management System procedures and regulatory requirements including ISO 13485, ISO 14971, 21 CFR 820, IVDR, CAP/CLIA/NYSDOH, ISO 15189, and related regulations and standards. 
• Support generation and analysis of Quality Indices reports (quality metrics) as part of Measurement, Analysis, and Improvement activities, rolling up into medical device QMR and clinical laboratory QMI meetings.
• Facilitate quality planning activities including optimizing planning tools, workflows, and documentation, and obtaining and communicating status, escalating effectively as needed to obtain executive awareness and support.
• Respond to process and software system-related inquiries and maintain effective cross-functional team communications to advance GRAIL’s quality activities and promote compliant and standard process execution.
• Lead software system configuration maintenance and improvements, including testing and validation, updating documents (SOPs, reports, protocols, specifications, etc.), as well as documenting, assessing, and resolving feedback to improve the end user experience.
• Cultivate positive relationships with cross-functional partners, leadership team members, and personnel executing and supporting these processes.
• Assess unusual circumstances and use sophisticated analytical and problem solving techniques to identify causes. Proactively resolve a wide range of issues in creative and compliant ways. Demonstrate technical proficiency, creativity, teamwork, collaboration with others, and regular independent thought.
• Exercise good judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining 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 with management.
• Participate in preparation for and execution of internal and external audits and inspections. Support timely and compliant responses to observations.
• Provide guidance to other departments and serve as subject matter expert (SME) on applicable regulations and standards.
• Perform other duties as assigned by management.

Required Qualifications:

• BS/BA degree & 8+ years of related experience, or Masters & 6+ years of related experience, or PhD & 4+ years of related experience.
• Working knowledge of applicable medical device regulations and standards including but not limited to 21 CFR 801, 21 CFR 809, 21 CFR 820, ISO 13485:2016, ISO 14971:2019, MDR/IVDR.
• Proven expertise remediating and improving a medical device CAPA process to ensure an effective, compliant, inspection-ready program.
• Experience using an eQMS required;
• Proven ability to efficiently manage workload under tight deadlines and pressure in a composed manner.
• Demonstrated ability to perform meticulous work with a high degree of accuracy and completeness.
• Experience supporting regulatory inspections/audits and responding to findings.
• Expertise managing data reporting and communications using tools including Smartsheet, Confluence, Google Docs and Google Slides.
• Proven leadership, organizational and management skills to drive effective, compliant cross-functional decision making.
• Excellent written and verbal communication skills and attention to detail.
• Ability to comprehend and interpret technical information related to GRAIL's product claims.
• Experience preparing for, leading, and supporting FDA and EU Notified Body regulatory inspections/audits and effectively responding to findings.

Preferred Qulifications:

• BS/BA degree & 10+ years of related experience is preferred.
• ASQ Certified Quality Auditor, Certified Quality Engineer, or similar preferred.
• Experience using Veeva Vault preferred.
• Experience working within a clinical laboratory (high complexity CLIA/CAP environment compliant with ISO 15189) preferred.
• Next Generation Sequencing (NGS) experience preferred.

Physical Demands and Environment:

• Work is performed in office, laboratory, and production environments.
• May involve occasional lifting of up to 25 lbs. and extended standing or walking in manufacturing areas.
• PPE such as safety glasses, gloves, or cleanroom attire required depending on assignment.
• Standard weekday schedule, with flexibility for extended hours during audits, inspections, or urgent quality issues.