To supervise and administrate the validations of the Computerized Systems. Coordinate and Maintain the Validation Master Plan including procedures, validation templates, and revalidations. Administrate the Software PLCs and Computerized Systems Inventory for the Plant, following the requirements in CFR Part 820 and 11.• Administrate the Validation Master Plan for Validations and Revalidations.• Assure that the requirements from ISO 13485, QSR Part 820 and 11 related to the control of… Show more To supervise and administrate the validations of the Computerized Systems. Coordinate and Maintain the Validation Master Plan including procedures, validation templates, and revalidations. Administrate the Software PLCs and Computerized Systems Inventory for the Plant, following the requirements in CFR Part 820 and 11.• Administrate the Validation Master Plan for Validations and Revalidations.• Assure that the requirements from ISO 13485, QSR Part 820 and 11 related to the control of Software and Validation Master Plan for Software are properly followed.• Maintain the Plant Validation Master Plan for Software’s and the templates for protocol reports in the System.• Conduct risk assessments, perform validation activities including IQ, OQ, and PQ, and manage software defects and issues.• Perform the annual review of the Plant Validation Master Plan for Software.• SME for SAP and MES systems.• Follow the Risk Analysis program for Software Validations.• Perform training in Validation requirements under a regulated environment following CFR Part 820, 11, ISO 13485, and GAMP 5.• Leader for CAPA’s, NCMRs, and complaints related to the Software Validation.• Perform and give support in the test scripts creation.• Audits quality systems for deficiency identification and correction.• Assists in the process of ensuring that corrective actions (CAPA) are completed, in accordance with relevant ISO requirements (ISO 9001 and ISO 13485), advanced problem-solving methods.• May provide direction and mentoring to less experienced Software Validations Engineers.• Give support in the Audits from 1st, 2nd, 3rd parties.• Ensuring the integration of validation activities into the product development lifecycle and implementing corrective actions based on audit findings.• Provide training and guidance to junior engineers. Show less

Responsible for facilitating the development and improvement of Information Systems ERP and MES to meet current and future business needs. Working closely with various teams to analyze requirements. prepare specifications, and oversee project planning and implementation, maintaining documentation changes through Engineering changes, testing and validating process execution during development process for eDHR and processes in production lines and driving continuous improvement through data… Show more Responsible for facilitating the development and improvement of Information Systems ERP and MES to meet current and future business needs. Working closely with various teams to analyze requirements. prepare specifications, and oversee project planning and implementation, maintaining documentation changes through Engineering changes, testing and validating process execution during development process for eDHR and processes in production lines and driving continuous improvement through data analysis and innovative solutions.System Development Support: Conduct inquiries to support the development of new information systems that align with current and future business requirements.Functional Specifications: Write detailed functional specifications for application development, enhancements, and testing to meet user needs.System Enhancement: Analyze user requirements, procedures, and problems to identify opportunities for improving existing systems.Documentation: Maintain comprehensive documentation for the responsible area, ensuring accuracy and accessibility.Training: Recommend and conduct training as needed to enhance system usage and efficiency.Troubleshooting: Serve as an escalation point for troubleshooting complex issues related to IT systems.Team Collaboration: Foster knowledge exchange and idea sharing within the department, encouraging input from team members.Cost Reduction: Identify creative ways to reduce costs by streamlining processes, eliminating non-value-added tasks, or re-engineering systems.Continuous Improvement: Drive continuous improvement efforts through trend reporting analysis and metrics management.Innovation: Offer new ideas and suggestions for process and system improvement, implementing "best in field" practices.Measurement Systems: Establish new measurement systems where possible to track and improve performance. Show less

Master Data Admin, Responsible to work with the Stagings in the QA and MFG team, by collecting and storing data, for the NPI, ECO and any updates for the products, setting up Inspection plans, Routings, BOM and Material Master and other information needed.Responsible to maintain the data for the products such as any changes required in the master data for the ERP system SAP.Responsible on creating new templates to validate the that the product information on the ERP system… Show more Master Data Admin, Responsible to work with the Stagings in the QA and MFG team, by collecting and storing data, for the NPI, ECO and any updates for the products, setting up Inspection plans, Routings, BOM and Material Master and other information needed.Responsible to maintain the data for the products such as any changes required in the master data for the ERP system SAP.Responsible on creating new templates to validate the that the product information on the ERP system is accurate for the MFG & QA execution in plant.Test processes in products before releasing them for production, implementing new workflow for the production order execution reducing time and risks in the setup and completing operations in the ERP system such as standard hours, Costs, Runtime, Machine Setup, Quality testing and signing products, materials good movements.Cross functional team execution, international meetings to schedule and execute setups through the Staging process for the NPI projects for two facilities Las Americas & La Romana. Show less

Data admin & Lead user, responsible for data collection for the SAP design in the Medical Device processes, giving ideas for the integration of the Planning, Logistics, Manufacturing, Quality & Incoming department. Routing remediation & configuration for all products in DR La Romana and Las Américas. Responsable to populate all the products documentation on a Excell file to design and port it on SAP, auditing data, Master Inspection Characteristics.Responsable to gather… Show more Data admin & Lead user, responsible for data collection for the SAP design in the Medical Device processes, giving ideas for the integration of the Planning, Logistics, Manufacturing, Quality & Incoming department. Routing remediation & configuration for all products in DR La Romana and Las Américas. Responsable to populate all the products documentation on a Excell file to design and port it on SAP, auditing data, Master Inspection Characteristics.Responsable to gather the Machine Validation documents to post it on SAP.Responsable to text the program and train other associates related to the process.Certificated as a lead user (Train the trainers) with the capacity to train others on SAP ERP processes. Show less

Responsable for giving support in (NPI) New Products Introduction, on different tasks like labor cost, layout, time study & standard work layouts.Routing remediation in terms of labor costs, change over, time study, layouts and SWL.Responsable for leading an root cause analysis on critical issues in a main line to reduce scrap and increase the output per hour. Brainstorming, time study, ECRS.