Shalini Ramesh Email & Phone Number

California, United States

Quality Lead - ERP implementation projectAs a people leader, trained and developed team on new processes, preparing for ERP implementationUDI DPO - EUMDR UDI Module ValidationLed the Divisional team in creating a process for submission of UDI data to EUDAMEDWorked with IS to create test scripts and was involved in testing the functionality in SIT and UATTrained Divisional team and worked on creating procedures and work instructions, and presented to cross functional SMEsWorked with cross- functional team to identify SOP/ WIs that require changes and tracked them for completionAs a workstream lead for Quality, worked on identifying gaps in processes like holds, recalls, batch/serial determination, Item Master

Worked on requirement gathering, gap analysis, implement system capabilities for UDI part of EUMDRAttended workshops, for testing new system implementations for EUMDR and other projectsPart of numerous NPIs, and implementation of new system capabilitiesCreated Divisional Procedures and workflows, based on Corporate guidance after completing gap analysisAs part of developing talent, trained cross functional team members

Process Owner for UDI implementation Quality team member for Product Life Cycle Management (PLCM)Up revved New Product Introduction Process pertaining to Item MasterWas part of Quality Audit ReviewsWorked on NCs and CAPAsCross trained functional team on new processes and systemsAttended CRPs, as part of testing new functionalities. UAT deliverables completedSystems worked on - ERPs - Oracle and SAP, PLM, Trackwise, Quickbase

Created new process Procedures - SOPs/ Work Instructions- WIs -streamlined processesCoordinated with cross functional team, IS to scrub data and reduce IS ticketsImplement UDI to submit data to GUDIDWorked on numerous NPIs (New Product Introduction), as part of Item Master leadDivisional Lead for Item Master for implementing Manufacturing/Planning ProjectsIntroduced new workflows with international teams, with proper communication and handshakesProactively addressed potential quality issues before they ariseIdentified areas of improvements by challenging our usual way of doing thingsProfessional expertise in ways that are unique and innovative

Prepared role responsibility matrix, design document based on legacy system set upDesigned and developed oracle menu and responsibility based on user rolesSupported CRP( conference room pilot) testing and tracked user issue log reportingModified menu structure design per CRP test feed back

Learned different technologies by pairing with experienced engineersDesigned, built and tested the core components of the “Portfolio Management Tool”Investigated solutions to the application requirementsWas responsible for the Presentation Layer of the projectDeveloped ER Diagrams, Class Diagrams to design the DatabaseUtilized Dreamweaver technology to develop Web PagesDeveloped and executed Test Cases and User Manual

Master'S Degree, General Engineering

Bachelor'S Degree, Electrical, Electronics And Communications Engineering