Hiram Pagan Schelmetty

Experience

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  Medisearch Puerto Rico

  Sept 2014 - Mar 2015

  Validation Engineer

  Conduct qualification tests of new or existing processes and equipment in accordance with internal protocols and external standardsPerforms Manufacturing Test Report and Component Performance Verification Protocol/Report to provide more manufacturing capacity, flexibility and redundancy to run products currently manufactured in Heat Sealing Machines.Performs Risk Assessment Report.Participated in the creation of Decommission Reports.Performs the Monthly Yield Data. This data contains top scraps offenders and yield trends month by month.Prepared a log with all the validations performed. Show less

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  CIQA Computer Integration of Quality Assurance

  Apr 2015 - Jul 2015

  Validation/Quality Engineer

  Participated in a cleaning validation assessment.Prepare and review, validations documentation related to analytical scales, in order to be in compliance with the USP <41>Prepare and execute Validation Protocols (IQ, OQ, PQ)Executed Instructions Test Procedure (ITP) included as part of the Operational Qualification. Basic training in equipment’s such as Kaye Validator 2000. Involved in the setup, calibration and post calibration of the Kaye Validator 2000 to support validation activities. Show less

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  Medtronic

  Aug 2015 - Dec 2015

  Quality Engineer

  Provide guidance and training to personnel and contract partners in the execution and review of validation related activities, including manufacturing procedures and protocols where applicable.Prepare, review, and approve validations documentation associated to Computer / Computerized SystemsParticipates in the Computer Validation Process of existing and new internally developed Custom applicationsWritten/Executed test cases as part of the Installation and Operational Qualification. Prepared and review documents related to internally developed software.Update quality and manufacturing proceduresEvaluate and review documentation, from Quality perspective, associated to computerized system, which includes document correctness, adequacy, and compliance with the regulatory policies, FDA 21 CFR Part 11 and Annex 11.Participate in the development of Project Implementation plan of new custom computerized systems. Show less

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  CIQA Computer Integration of Quality Assurance

  Jan 2016 - Mar 2016

  Project Engineer

  Responsible for delivering projects against agreed scope, budget, schedule & customer expectations. Doing this while supervising, directing & motivatingteams of multi-discipline contractors.Monitoring project to identify potential problems and proactively identifying solutions to address them in advance.Escalating promptly any issues that may impact operations.Development of 3D models design.Providing strategic direction during the implementation stages.Monitoring staff & team performance. Show less

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  LifeScan

  Mar 2016 - Jul 2022

  Validation Consultant

  Execute Cleaning Validation protocol on a teamwork environmentDevelop and execute DOE, Characterization protocols, attribute Agreement Analysis and gage R&R and performs analysis of the data Update Preventive Maintenance, Operational and Machine Operational and set up work instruction based on PFMEA mitigation strategies.Keep track of the validation activities in order to prevent or reduce potential problems that delay the validation activitiesTest Methods Validations – Gage Repeatability and Reproducibility by Variables and Attributes. Develop and execute Attribute Agreement Analysis for vision system that make decision of product qualityOperational and Process Qualifications SupportDeviations Investigations with Statistics Application Show less

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  Abbott

  Apr 2017 - now

  Leaded Investigations, exception reports, corrections, Health Hazard Evaluation (HHE), CAPA (Corrective Action/Preventive Action) activities and support on Complaint Investigations.Served as primary QA (Quality Assurance) personnel supporting the day-to-day manufacturing operations.Participated in continuous improvement projects as necessary and overseeing the change was implemented and sustainable.Maintained procedures and Managed changes as needed. Served as Approver for First Article Inspections and Change Orders generated for document changes, validations, drawings, among others.Performed and reported line defects trend analysis, cost of quality, and period quality summaries.Performed duties that support the Manufacturing Operations such as Project Quality Plan, Build at Risk assessment, product disposition, among others.Supervised the Quality Control Inspectors and Quality Control Technicians. Show less

  • Engineering Manager

    Jul 2022 - now

  • Senior Quality Engineer

    Apr 2017 - Jul 2022