Staff Quality Engineer, Complaint Handling / Post Market Surveillance

Overview

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. For more information, please visit grail.com This position is a key individual contributor in the Sustaining and Post Market Quality organization, responsible for executing, maintaining, and improving the Sustaining and Post Market Quality elements of GRAIL’s quality management system (QMS). 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 proactively identify and solve complex problems, effectively communicating status and recommendations to management. Primary responsibilities include facilitating and supporting Complaint Handling/Post Market Surveillance. This individual contributes to a positive environment of accountability and performance excellence. This individual may represent the Quality organization during audits and inspections as well as on various project teams as determined by management. This role is based at our Durham, North Carolina, office and offers a flexible working arrangement. 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.

Responsibilities:

• Support Quality Operations through expert interpretation, establishment, and execution of quality 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.
• Use proactive, creative problem-solving to contribute to development of concepts and principles to achieve goals and objectives.
• Demonstrate technical proficiency, creativity, teamwork, collaboration with others, and regular independent thought.
• Exercise excellent judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
• Act independently to determine methods and procedures to successfully complete assignments.
• Structure day-to-day work autonomously, effectively communicating status and issues with management.
• Identify and evaluate deficiencies and improvement opportunities, working cross functionally to resolve and improve on existing processes.
• Create and support a quality culture by driving compliance activities around the Complaint Handling/Post Market Surveillance Program, partnering across the organization to manage continuous process/quality improvements that strongly align with GRAIL procedures and customer (internal and external) needs while meeting all applicable regulations and standards.
• Lead and support quality system process improvements, workflow implementations, and system configurations associated with the Complaint Handling/PMS Program.
• Generate and maintain post market surveillance plans and reports.
• Partner with GRAIL Customer Service Team and Medical Information Team to facilitate feedback evaluation, complaint investigations and closure across all GRAIL sites. Perform assessments for reportability on adverse events, impact/risk, and trend analysis.
• Provide Quality oversight, including review, feedback, and approval for Complaint Handling/PMS Programs.
• Respond to all inbound complaint related inquiries and maintain effective cross-functional team communications to advance GRAIL’s quality activities and promote standard methodologies.
• Support generation of Quality Systems metrics, which roll up to Quality Indices and Key Performance Indicators, and Quality Management Review.
• Cultivate positive relationships with key partners, leadership team members, and other cross-functional partners throughout GRAIL, including third-party vendors/consultants.
• Implement programs to comply with all applicable regulatory requirements including 21 CFR 820, ISO 13485, and ISO 14971, IVDR, ISO 15189, 21 CFR Part 493 (CLIA), CAP, New York State Department of Health (NYSDOH), and related regulations and standards.
• Represent complaint handling/PMS on sanctioned cross-functional projects driving toward effective, on-time completion of business goals and objectives.
• Drive a culture of quality across the organization with the goals of efficiency, compliance, and continual improvement.
• These responsibilities summarize the role’s primary responsibilities and are not an exhaustive list. They may change at the company’s discretion.

Required Qualifications:

• Degree in science, engineering, or other technical area, or equivalent experience.
• Minimum of 8 years of experience working within a medical device, pharmaceutical, or biotech quality management system, with at least 4 years direct involvement in administering Complaint Handling/Post Market Surveillance Programs.
• Experience using an eQMS
• Working knowledge and understanding of regulations and standards, including but not limited to QSR, ISO 13485, Quality System, CAP/CLIA, NYS, ISO 15189 and other applicable industry requirements.
• 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.
• Demonstrated project management experience developing processes and leading their implementation in a cross functional environment.
• Experience supporting regulatory inspections/audits and responding to findings.

Preferred Qualifications:

• Experience using an eQMS, preferably Veeva Quality Suites.
• Excellent written and verbal communication skills.
• Proficiency with standard office software applications including Microsoft Office, Google Suite, and Zoom

Physical Demands and Work 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.