Quality Engineer 2, Quality Operations - Clinical Laboratory # 4790
Job Description
This position is a key individual contributor in the Quality Operations organization, responsible for executing, maintaining, and improving the clinical laboratory Quality Operations elements of GRAIL's quality management system (QMS). This role's focus is on GRAIL's clinical laboratories, supporting the medical device processes as needed with consideration for the single GRAIL quality management system. 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 solve problems of moderate scope, which are often varied and routine where analysis of situations or data requires a review of a variety of factors, effectively cascading decisions across teams and communicating status and recommendations to management.
Primary responsibilities include supporting the clinical laboratory alternative performance assessment (APA) program, equipment program, CAP checklists, supporting completion of clinical laboratory Quality Indices reports, Quality Monitoring and Improvement (QMI) meetings, and executing and facilitating clinical laboratory quality workflows including NCRs, planned deviations, CAPAs, validations, complaints, risk management records, change management and document change controls. This individual contributes to a positive environment of accountability and performance excellence. This individual represents Quality Operations 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.
This position is a key individual contributor in the Quality Operations organization, responsible for executing, maintaining, and improving the clinical laboratory Quality Operations elements of GRAIL's quality management system (QMS). This role's focus is on GRAIL's clinical laboratories, supporting the medical device processes as needed with consideration for the single GRAIL quality management system. 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 solve problems of moderate scope, which are often varied and routine where analysis of situations or data requires a review of a variety of factors, effectively cascading decisions across teams and communicating status and recommendations to management.
Primary responsibilities include supporting the clinical laboratory alternative performance assessment (APA) program, equipment program, CAP checklists, supporting completion of clinical laboratory Quality Indices reports, Quality Monitoring and Improvement (QMI) meetings, and executing and facilitating clinical laboratory quality workflows including NCRs, planned deviations, CAPAs, validations, complaints, risk management records, change management and document change controls. This individual contributes to a positive environment of accountability and performance excellence. This individual represents Quality Operations 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.