Complaint Handling Business Unit Senior Manager
CurrentAs the Senior Manager for the Complaint Handling Unit, I’m the investigation process owner for the Cardiovascular Specialty Solutions division (CSS) including all Johnson and Johnson medical device franchises (Biosense Webster Inc., Mentor, Cerenovus, Acclarent and Sterilmed). I’m accountable for the compliant handling, leading the investigation team for timely execution of complaint evaluation, product investigation, and issue escalation according to applicable laws and worldwide regulations. Some of my responsibilities are: Participate in decision-making regarding Medical Device Reporting and vigilance based on results of complaint product investigations. Engage with customers, sales representatives and patients as required, participation in external and internal audits. Motivate, inspire, train, and develop my team, lead NC’s, CAPA and field actions as required. Execute improvement and efficiency projects to keep metrics performance and support NPI.