Robin Osete

• Processes change orders, ranging from simple-to-complex, for the creation and revision of product, process, and system designs.
• Reviews and analyzes change data provided by all functions and facilitates coordination of changes with applicable stakeholders, including engineering, quality, manufacturing, operations and regulatory.
• Reviews and verifies Executive Summary and BOD documents changes, Verifies Excel File of BOD document revisions at time of BOD creation and any subsequent Excel files created from prior BOD releases.
• SME in the QMS process, prepares, updates changes.
• Manages the change order process and prepares for change approvals by stakeholders.
• Prepares change management status reports.
• Ensures customer requirements are implemented while maintaining compliance to applicable policies, procedures, regulations, and standards.
• Functional Skills: Change Control, Document Management, Compliance, Product Lifecycle Management, Electronic Document Management Systems, Enterprise Resource Planning (ERP) Systems.
• Updates and review's Design History files for sustaining projects for project / business data .
• Additional Skills: Problem Solving, Detail Oriented, Cross-Functional Collaboration, Customer Service, Process Improvement, Communication.

(Contractor) Medtronic Diabetics, Northridge, California – Document Control

• Analyzing documents,(RE’s, PC’s) paper, materials, drawings - release, decline, per corporate, department procedures and policies.
• Create/update documents, and materials for various doc types in SAP.
• ECR/ECO’s (Engineering Change Orders) from start analyzing to the release process.Under the direction of senior configuration.
• Interface with creators via Phone & Email notifications for communication on documents, materials and ECO’s.
• Verifying accuracy and file appropriate evidence of preforming transaction /changes with the ECO, documents and materials.
• Maintain department documents data base, per corporate and department procedures. Good documentation practices.
• Revise documents, materials, in SAP transactions and CAD Drawings in Solidworks.
• Answer various questions on programs, documents, SAP, help desk,
• Maintain files in SAP, Solidworks (electronic files) Drives, and back room files. Including Standards.
• Run reports for various tasks, CCB/PQRB meetings./ RE & PC set up/ Backup.
• Assist in back room when needed, Scanning, Filing, and special projects.
• Transfers electronic files, including CAD files into a secure network.
• Archives Fifeshare, e-files request, print request, software request,
• Special project- setting up the standards in the file room and SAP. (continuing)
• Step in when needed without having to be asked, Team work.