Senior Quality Engineer, Complaint Handling # 4699

This position is a key individual contributor in the Quality Operations: Clinical Laboratory 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 and Post Market Surveillance (PMS) activities. This individual contributes to a positive environment of accountability and performance excellence. This individual may represent the Quality Operations during audits and inspections as well as on various project teams as determined by management. This position will require regular on-site presence at the discretion of management.

This role is based in Menlo Park, California, and will move to Sunnyvale, California, in Fall 2026. 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 40%, or 16 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 40% requirement for the site. At our Menlo Park campus, Tuesdays and Thursdays are the key days where we encourage on-site presence to engage in events and on-site activities.

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 Complaint Handling and Post Market Surveillance Programs, 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 Medical Device Regulations and Standards.

• Support continuous quality system process improvements, workflow implementations, and system configurations associated with Complaint Handling and PMS Programs.

• Partner with GRAIL Customer Service, Medical Information, Clinical Surveillance to facilitate feedback evaluation, complaint investigations and closure across all GRAIL sites. Perform assessments for reportability on adverse events, impact/risk, and trend analysis.  

• Evaluate and i