The Opportunity

Incumbent serves as process owner and overall responsibility for Complaint Handling. They are the subject matter expert and representative for the Formally Designated Unit (FDU) and serve as a primary contact for the overall complaint handling process during audits, inspections and assessments by regulatory agencies, globally. Works closely with Commercial Teams and Commercial Senior Management to ensure that worldwide Customer Service functions follow global regulations and divisional procedures for call registration and complaint handling. This includes development of strategies for the Commercial Organization as they relate to complaint handling. Additionally this position is responsible for personnel development and assessing performance. Provides direct and indirect supervision to professional, direct or indirect labor staff to ensure that complaints are handled in accordance with global regulations. Ensures that compliance is maintained and that employees are trained and following the required divisional and Abbott policies and procedures. Interacts with division's Senior and Executive management in the area of complaints handling and issues affecting product performance. Anticipates, recognizes, communicates and manages quality issues within the organization and works with appropriate cross-functional areas to recommend actions to resolve issues. This position will be based out of our Abbott Diabetes Care in Alameda, CA and the individual will be expected to be onsite Monday-Friday. What You'll Work On Responsible for implementing and maintaining the effectiveness of the quality system. Identifies and recruits staffing / resources to support complaint handling activities and on-market support for multiple product lines deemed critical to success of financial performance for the Division. Identifies and implements the organizational structure necessary to achieve business objectives and QA compliance within the complaint handling organization. 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. Champions and actively participates in development / improvements of complaint handling processes and procedures. Work 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. Works 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. Facilitate meetings and discussions across multiple organizations as required to improve/enhance complaint handling processes. Interacts with Senior and Executive level staff to escalate field compliant issues as necessary. Monitor incoming complaints for increasing trends and alert management when a product issue is emerging. Participate in monthly tracking and trending meetings - provide input on early trends that may not yet be reflected in the data. Responsible for ensuring that customer complaints are reviewed in a timely manner and elevated to the medical events group as necessary to meet reporting regulations. Responsible for ensuring that product quality issues are identified as early as possible and remedied through the corrective and preventive action system. The incumbent also has a significant interaction with FDA / ISO during inspections. Required Qualifications Bachelor’s or Master’s degree in Engineering, Life Sciences, Regulatory Affairs or a related field or equivalent combination of education and work experience. Minimum 8 years of Quality experience in medical devices or pharmaceutical regulated environment. Minimum 3 years managing/leading organizations. Substantial knowledge of CFR 820, 803, 806, ISO 13485 and ISO 14971. Minimum 5 years Complaint Handling Experience. Preferred Qualifications: Excellent organizational, communication, and problem-solving skills. Demonstrated ability to adapt quickly and work effectively both independently and collaboratively within cross-functional teams in fast-paced, dynamic environments.