Senior Quality Specialist - CAPA # 4408

Responsibilities:

• Facilitate and coordinate the CAPA program, NCR program, quality metrics, and quality planning process.
• Maintain and improve these programs 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. 
• Lead regularly scheduled meetings to ensure timely and compliant completion of Nonconformance reports (NCRs), obtaining and communicating status and escalating effectively as needed to obtain executive awareness and support.
• Coordinate the CAPA Review Board, ensuring timely and compliant completion of CAPAs, obtaining and communicating status and escalating effectively as needed to obtain executive awareness and support.
• Coordinate generation and analysis of monthly 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.
• Maintain, improve, and facilitate training and competency programs for the CAPA and NCR processes.
• 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.

Responsibilities:

• Bachelor’s degree in science, engineering, or other technical area.8+ years of related experience (Masters 5+ years) working within a medical device, pharmaceutical, or biotech QMS, with expertise in CAPA, NCR, and metrics reporting.
• Demonstrated knowledge and understanding of applicable regulations and standards, including but not limited to QSR, ISO 13485, CAP/CLIA, NYSDOH, ISO 15189, IVDR.
• Experience using an eQMS required; Veeva Vault preferred.
• 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.
• Excellent written and verbal communication skills.
• Expertise managing data reporting and communications using tools including Smartsheet, Confluence, Google Docs and Google Slides.
• ASQ Certified Quality Auditor, Certified Quality Engineer, or similar.