Phyllis Whitaker

• Managed a queue of Medical Device Reports (MDR) for potential adverse events from draft through FDA submission, including the reportability decision tree execution

• Managed the technical writing process of failure analysis letters within SAP

• Led a remote team to manage medical device complaints for Infusion Pumps and IV Sets

• Led a remote team to update package labeling for Class I, II, and III products with updates specific to (EU)2017 MDR 745/746

• Assessed 8 to 10 Supplier Complaints of third-party drug products per week, including tracking related emails, complaint documentation, communication of complaint resolution, and monthly reconciliation reports

• Assigned appropriate Product Experience (PE) Codes, with an average 91% accuracy, within SalesForce, to assist with domestic reporting of Medical Device Complaints

Quickly onboarded to Abbott's systems, completing the required training to support the documentation and
technical writing of the change control process 14 days early
Attended meetings to gain a better understanding of the change management process at Abbott
Surveyed and toured the plant floor to gain an understanding of the business operation
Supported cross-functional teams by providing accurate, timely, and well-organized document revisions
for various projects
Managed the document change control process by working with the Document Center to gain approval for
document changes
Successfully implemented changes in cleaning procedures that improved the microbiological
environmental monitoring passing rate over 90%