The Sr. Complaint and CAPA Specialist is responsible for leading and executing complaint handling and corrective and preventive actions. As the subject matter expert, you will ensure compliant documentation and complaint handling and CAPA’s to meet global requirements. Key skills required for this role are a deep understanding of medical device complaint handling requirements, strong analytical skills and excellent communication ability.This role is located at the Sirtex Woburn facility with an expectation to work in Sirtex Wilmington when investigating complaints.  Our current hybrid structure is 3 days/week in office and 2 days/week remote.Responsibilities:Lead and Coordinate documenting, evaluating, assessing, and investigating feedback and complaints to meet regulatory requirementsMaintain accurate compliant entry of complaints while working with quality engineering and regulatory affairs to investigate and document complaintsEnsure appropriate response and timely follow up to customer complaints including escalation, investigation and communicationPrepare customer letters acknowledging receipt of the complaint, initiate return of product(s), outline the findings of our investigation and other appropriate follow upDevelop and maintain a training program on complaint handling for a global organizationDrive the complaints through resolution and closing, by gathering additional information as needed, working with cross-functional departments on proper investigations and ensure follow-up is completed and documentedEscalate issues as needed, including trends in data through coordination and communication to the Complaint Board Track and ensure proper investigation, associated corrective/preventive action, as well as verification activities that stem from customer complaints, internal/external audit findings, failed product testing of any kind, deviations from policy and procedures or any adverse eventsWork with and lead cross functional teams from documentation of initial problem through investigation, root cause, impact assessment, implementation and verification of effectiveness (VoE) Coordination, communication and execution of CAPA board process
