The Sr. Complaint Handling Unit (CHU) Manager is responsible for complaint handling and is the process owner for complaint analysis, regulatory reporting, and complaint management. This role will be the subject matter expert, working closely with Commercial, Operations, and Design teams, and interacting with regulatory agencies and customers to ensure the Complaint Handling Unit follows complaint handling procedures and regulations. The manager is responsible for implementing and maintaining the effectiveness of the quality system, including personnel development and assessing performance. They provide direct and indirect supervision to professionals to ensure that complaints are handled in accordance with Quest policies and procedures. The manager communicates with management regarding complaints handling and issues affecting product performance, anticipating, recognizing, communicating, and managing quality issues within the organization, and working with appropriate cross-functional areas to recommend actions to resolve issues. They manage day-to-day complaint assignments and support management in day-to-day operations in a fast-paced work environment. The manager ensures complaints are evaluated against criteria for potentially reportable events and elevated to the medical events group as necessary to meet worldwide medical event reporting requirements. They champion and actively participate in the development and improvements of complaint handling processes and procedures, ensuring that customer complaints are reviewed in a timely manner and elevated to the medical events group as necessary to meet reporting regulations. The manager is responsible for ensuring that product quality issues are identified as early as possible and remedied through the corrective and preventive action system. They participate in monthly tracking and trending meetings, providing input on early trends that may not yet be reflected in the data. The manager works effectively with Customer Service and R&D, as well as other internal and external organizations as needed, to coordinate and facilitate improvements in complaint handling processes. They work closely with Complaint Investigation, Supplier QA, and Operations teams to ensure that exception reports and corrective and preventive actions are conducted as necessary for complaint issues. The manager facilitates meetings and discussions across multiple organizations as required to improve/enhance complaint handling processes. They interact with Senior and Executive level staff to escalate field compliant issues as necessary and have a high level of interaction with FDA and global regulatory agencies, including routine communication and inspections. The manager partners with other quality professionals and cross-functional teams to address recurring issues identified throughout the organization, manages customer relationships and expectations during the course of complaint investigation and resolution process, and ensures compliance with all federal and international regulations/standards. They identify and implement appropriate corrective actions based on complaint analysis to prevent recurrence of issues.