Celeste Peña, MEM

Experience

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  Edwards Lifesciences

  May 2010 - Aug 2016

  * Technical support to validations of critical equipments which support manufacturing area.* Investigation of different types of non conformances: Identifying root causes through different quality tools and addressing them with corrective/preventive actions.* Support with internal and external quality audits.* Subject Matter Expert (SME) as a compliance engineer to Maintenance and Facilities Area.* Ensure adherence to procedures and regulations.* Identify and Implement Improvements.Accomplishments: *Audit Findings Past Due reductions from 85% to 0% in three (3) months.* Facility Quality System Timeliness in 100% above plant metric established.* Validation of a new version of Software MAXIMO to enhance the maintenance system of the company.* Validation of critical equipments such as: Air Handlers, Hand Dryers, Construction Qualification Protocols due to changes in manufacturing area. Show less

  • Compliance Facilities Engineer (Engineer II)

    Mar 2013 - Aug 2016

  • CAPA System Administrator (Engineer I)

    Jun 2011 - Mar 2013

  • NCR Administrator (Technician)

    May 2010 - Jun 2011
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  BMA Group Global

  Oct 2016 - Oct 2017

  Sr. Quality Engineer (Contractor)

  Working as Quality Engineer supporting New Project in Edwards Lifesciences Costa Rica Operations.Working with the HVT Engineering team with creation of Part Numbers, Procedures, Training Plans, Protocols to start operations in Costa Rica Site.

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  Fenwal, Inc., a Fresenius Kabi Company

  Nov 2017 - now

  • Associate Manager QE & Complaints Investigations

    Sept 2024 - now

  • Principal, QE and Complaints Investigation

    Sept 2023 - Sept 2024

  • Superintendent, QE and Complaint Inv.

    Jan 2022 - Sept 2023

  • Quality Engineer III

    Feb 2021 - Dec 2021

  • Quality Engineer II

    Nov 2017 - Feb 2021