Tori L Perry

• Manage and execute multiple franchise labeling (product label and/or IFU) and packaging configurations to comply with EU MDR Labeling language requirements.
• Utilize Product Lifecycle Management (PLM)-Windchill system to create and execute change requests and change notices for tracking and approval of label revisions through the change workflow process and ensure that the label aligns with project plan.
• Update and maintain status of each job in accordance with the applicable project plan and job tracker
• Escalate issues and delayed activities to project leads as necessary
• Verify the completeness and accuracy of product data from franchise requester by creating MSPTR (Master Specification Product Requirement) forms and process through PLM system.
• Effectively collaborate and remain aligned with MDR E2E Stakeholders including Regulatory Affairs, Quality Engineer, Labeling Design Team, Deliver Sites (Distribution Center) for planning and processing.
• Created Intake form for each MSPTR and submitted to Distribution Centers for printing labels and IFU.
• Establish and maintain active product codes by creating component assignment and component master using the RSC (Right Stage Customization) system following a approval process.
• Uploaded European MDR product master data into ERP SAP P01 system for labeling compliance at the European distribution site.
• Create, manage and process transformation orders executed within a deliver transformation site by using the RSC systems Product Transformation Module.
• Regularly monitor and respond to emails, perform required task in line with the projects demand.
• Onboard, assign and track training for 36 employees along with assisting with access to different systems.
• Participated in Centralized Meetings with various JnJ sites for project transition to new software.

• Verify accuracy of labels submitted by proofreader
• Track department training and assign as needed
• Create job aids
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• Reviewed, proofread and corrected content for accuracy of grammar, spelling, punctuation, syntax and formatting.

Serve as a Global Labeling core team member for Zimmer Biomet labeling initiatives. Work with Regulatory, Development, Brand, Packaging Development, and other departments to develop/create labeling that complies with US, EU, OUS, and UDI labeling regulations and requirements, as required. Initiate change requests for new and revised labeling, work with Labeling Coordinators to create, maintain, and implement compliant labeling. Review product labeling against indicated content to ensure compliance with labeling regulations and requirements (US, EU, OUS and USI as required), and approve change request to release labeling documentation for production/manufacturing label usage.

• Core Team member for Project Polaris which is a large remediation project of over 10,000 labels for implementation of label design and content accuracy.

Subject Matter Expert and Site Coordinator for several Quality processes and programs such as master data entry and verification for Development, Marketing and Quality Engineering into SAP ERP system, for validation studies and to set inspection for production. Work with Supplier Quality Engineers and Purchasing to maintain Approved Supplier List (ASL) and Supplier Change Requests (SCR) in Adaptiv. Responsible for all US Stop Shipment communications internally and externally. Assist in write up/rescission, attend Product Review Investigation to determine patient safety, track and send weekly corrective action updates assigned to Engineer and create/update monthly metrics for open and closed (US and Internationally), initiate International Stop Shipments as necessary. Maintain Stop Shipment procedure and form along with other metrics for non-conformances

• Participated on SAP ERP committee for conversion from Agile to SAP. Included several global conference calls and meetings, testing activities for system verification and training Engineers.
• Created metrics to track closure of Stop Shipments in 90 days or less, updating the Stop Shipment form for easier completion and better define roles and responsibilities. Metrics improved within less than 2 months.
• Act as point person during regulatory auditing and agency inspections.
• Planned, Coordinated and Executed Quality company function for over 1,000+ people. Organized committee, inside and outside vendors within set budget. Presented to Worldwide VP of Quality so other facilities worldwide could replicate.
• Planned, Coordinated and Executed departmental team building activities for over 25+ people and within set budget.
• Selected to represent DePuy as a participant in the Kosciusko Leadership Academy class of 2017.

Highly motivated, great customer service and prioritization skills with ability to multi-task to support up to 50+ individuals. Managed Failure Investigation Reports for the company, Quality Training Coordinator for 100+ people, responsible for tracking and training of company procedures. Enter and maintain criteria in AS400 for Engineering department. Create purchase orders, track orders, follow-up with vendors and receive product. Facilitate coordination for all departmental functions (daily, monthly and quarterly) such as team meetings, catering, team building events, etc.

• SME for Quality criteria retrieval documentation for litigation investigations
• Coordinated training of company procedures for Warsaw Quality organization of 100+ employees. Created and maintained tracking spreadsheets, worked with other department admins to train them on departmental training process.
• Assisted with criteria transition from obsolete AS400 system.
• Assisted Customer Quality team to absorb additional workload. Contact sales reps/territories for product retrieval/verification forms, enter packaging complaints in EtQ Complaint Database and contact all territory offices to monitor product return for investigation. Complete complaint summaries for follow-up to FDA.