Senior Complaints Investigation Specialist I

Job description

Our Work Matters At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make The Senior Complaint Specialist will provide technical leadership and subject matter expertise for the complaints department. This role will focus on overseeing complaint investigations, as well as assisting with metric tracking, complaint trending, complaint reviews including reviewing for potential regulatory reporting, and the issuance and tracking of Field Alert Reports (FARs). ESSENTIAL DUTIES AND ROLE RESPONSIBILITIES: - Serve as the subject matter expert for Quality Management System (QMS) complaint module. - Assist with metric tracking including metrics reported at Tier meetings, monthly reviews, and quarterly reviews (i.e. Quality Management Review) - Review complaints to determine if regulatory reporting is required, and issue reports (i.e. FARs) as required by site procedures, quality agreements, and applicable regulations. - Review and assist in complaint investigations and provide corrections and feedback to ensure that investigations are error-free, comprehensive, and aligned with procedural and regulatory requirem...