Luis Eduardo Gómez Rodríguez

Experience

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  National Center for Biotechnological Innovations

  Jul 2019 - Nov 2020

  Bioprocess Researcher

  - Assistance in Biotechnogical Assays regarding biological fermentations of Trichoderma fungus performing isolations, perform culture media, perform kinetical data analysis and sample collections.

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  Boston Scientific

  Nov 2020 - Jun 2022

  Quality Assurance Engineering

  - Handling of non-conformities related to material and system issues in a Core Team with three production lines and 10 different products. Achieving the reduction in the nonconformities opened related to practice against procedures by the operators in a 68% during the 2021. April 2021-June 2022.- Participation in a transfer project looking up for savings, transferring a bifurcation assembly from Spencer plant to Coyol plant, participating in the revision of the validations and documentation update needed (Test Methods, Risk documentation). May 2021- October 2021.- Ownership of a CAPA for complaints reduction related to a product, leading the Problem-Solving analysis and the investigation of the Root Cause and solution proposed . October 2021- May 2022. - Experience as Backroom Runner in External Audits/ FDA Inspection at the Coyol plant From September 2021- June 2022 obtaining experience as quality system representative in several roles in external audits (surveillance) of ISO13485:2016, EUMDR: 2017/745 and FDA inspection at the Coyol site.- Part of the new product development quality team, working in validations of processes, design freeze revisions from November 2020- April 2021 .- Quality Review Board owner (monitoring & following up CAPAs, quality improvements, process controls and key process parameters) Show less

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  ECI

  Jun 2022 - Aug 2023

  Engineering Consultant

  - Corporate QMS Remediation Project in medical devices industry, supporting the acquisition of new sites in Europe to the company, assessing changes in global documentación:, quality policy, procedures, work instructions.- Leading remediation projects creating Gantt Charts and using Agile methologies to track the project outputs. Achieving the remediation of more than 600 documents.- As QMS Program team member, participating in training sessions performed in the acquired sites in Switzerland, in order to establish the QMS requirements of the company.- Development of dashboards in Power Bi to visualize the Global change control tasks and track the remediation projects KPIs and comments/ feedback/ questions from the training sessions given in the acquired sites in Switzerland.- Project Manager in documentation remediation projects within the Global Quality Management System, leading a group of five Quality Systems Engineers, creating Gantt Charts, Power Bi reports, measuring KPIs and assessing the release dates for the impacted documentation. Show less

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  Intel Corporation

  Sept 2023 - now

  Quality Systems Engineer

  - Leading actions of the Internal Audit Program. Planning, scheduling and execution of the internal audits and leading the verification process of all the systemic actions defined during the audits to address systemic gaps in Costa Rica plant. Managing Power Bi reports to avoid the overdue of the actions defined achieving the creation of several working groups for systemic issues identified during the internal audits. (ESD compliance, WIP management, process controls & troubleshooting) creating robust solutions and achieving the reduction of the verification process aging in Internal Audits from 266 days average to 126 days average. - Leading the Self Audit Program in Costa Rica plant, as a Project Manager role, training Engineering resources as auditors to execute and document Self Audits, improving the prevention of quality events and reinforce the continuous improvement of the organization. - Management of the document control system, aligning expectations from the Global Quality Systems team to Costa Rica plant in order to standardize the type of documentation permitted in the Factory Floor. Managing the indicators of releasing, translation and notification of the impacted documentation.- Project Manager from Top Management quality initiatives as (Quality Management by walking around). Leading the planning and preparation process, execution, measuring, monitoring & reporting out the results to Top Management. Show less