Quality Engineer, Complaint Handling​/Post Market Surveillance

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.

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 role interacts with departments throughout the organization, including 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 and 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. The flexible work arrangement policy requires that a minimum of 60%, or 24 hours, of your total work week be on‑site. The specific schedule will align with team and business needs and could exceed the 60% requirement for the site.

• Support Quality Operations through expert interpretation, establishment, and execution of quality concepts and principles in accordance with GRAIL’s QMS 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 to select 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 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 and quality improvements that align with GRAIL procedures and customer 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…