Currently, I am working with suppliers to communicate complaints and requests for device history records for the global complaints group. Provide assistance for SR. QE's in managing and coordinating approvals for Supplier Change Requests (SCN's). As well as provide rejection communications to suppliers.

I am currently working in the UDI - (Unique Device Identifier) group. Responsibilities' include managing Supplier Change Notification processes, and ensuring compliant implementation of all suppliers validation activities meet FDA deadlines and directives.

Managed and coordinate the complete complaint process for medical devices. Duties include ensuring timely reporting of MDR/MDVR’s to remain in compliance domestically and internationally adhering to strict company and federal regulations. Coordinate and generate metrics for weekly meetings. Coordinated training for sales representatives and customer service personal on complaints reporting and recalls.

Generating visual labels, statistical data collection.