Carrie Allen

• Streamlined project management processes by implementing new organizational tools and software.
• Enhanced team collaboration through regular meetings, fostering a positive work environment for increased productivity.
• Improved client satisfaction with timely updates and transparent communication throughout the project lifecycle.
• Assist engineers with the initiation of product hold orders in a timely manner
• Collaborate globally and cross-functionally to execute on product hold order involving the following functions: Customer Service, Post Market Quality, Distribution Centers, Manufacturing Facilities, among others
• Use industry-regulated processes and systems such as SAP, EFAS, and Factory Works to administer product holds, reconciliation and tracking
• Provide status updates; serve as point of contact related to PHO process activities
• Coordinate actions with product held with distribution centers
• Drive final disposition and PHO closure by effectively communicating cross functionally
• Ensure completion of activities according to established timelines
• Coordinate product hold orders with field advisories and recalls
• Monitor PHO process to ensure compliance with quality procedures and regulatory requirements.
• Use systems to generate reports identifying the location of products affected by the recall
• Prepare with printing and mailing of field advisories
• Support audit and regulatory investigations
• Monitor customer responses to field advisory notifications
• Store FCA and PHO quality records
• Weekly ExComm reports

• Maintained confidentiality of sensitive information by adhering to strict privacy policies and implementing secure filing systems.
• Delivered excellent customer service through prompt responses to client inquiries, addressing concerns effectively, and building strong relationships.
• Ensured accurate record-keeping with diligent data entry and database management for vital company information.

Regulatory Affairs

• maintain product files & foreign government files
• tracking of ECO's and literature reviews
• provide back-up for the product managers
• general telephone back-up

Regulatory Compliance

• maintain files on Medical Device Reporting, Field Action, and Inspections
• retrieve doctor's addresses from DRS system
• assist in Field Action mailings
• clerical back-up
• other miscellaneous duties involving the DRS/VAX systems

Maintain Audit Report files

• Prepare and assemble audit information specific to each audit
• Tracking and recording the distribution and retrieval of audit reports
• Ensure compliance to the retention policy for audit reports
• Execute the destroying of audit reports and electronic files as specified by the procedures.
• Maintain/update policy and procedure manuals from each facility, as well as internal and the Pacing Business dept.
• Provide support for the corrective action responses through data entry and tracking the receipt of status
• Coordinate the generation and distribution of the Quality Audit Status Report

• Entered data into system and updated customer contacts with information to keep records current.
• Safeguarded sensitive information by maintaining strict confidentiality protocols when handling personnel files or company documentation.
• Input data and processed system change to generate accurate reports.
• Created and updated records and files to maintain document compliance.

• Safeguarded sensitive information through proper handling of confidential correspondence according to company policies.
• Reduced delivery errors by diligently sorting and categorizing mail according to recipient names, departments, and zip codes.
• Enhanced customer satisfaction through timely and accurate mail distribution within the organization.
• Maintained a well-organized mailroom, ensuring easy access to materials and efficient workflow for staff members.
• Sorted and placed mail into mailboxes and post office boxes with high levels of accuracy.
• Processed and organized incoming mail for distribution to appropriate departments.
• Weighed letters and packages and calculated costs based on classification, weight, and destination.
• Contributed to a positive work environment through maintaining a clean, organized, and safety-compliant mailroom facility.
• Labeled packages with clear, correct information to reduce mailing errors.