Experience

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  Edwards lifesciences

  Jun 2003 - Jun 2007

  Coordinated and conducted independent investigational testing and analysis to identify device failure modes.Prepared technical findings reports, summaries, and quantitative analysis.Maintained accurate and complete records, methods, measurement and observations related to assigned projects on product evaluations.Lead and participated in cross-functional teams (CAPAs) and in special projects related to evaluation of existing and developmental products/processes. Performed Limulus amebocyte lysate testing (LAL) and chemical solution testing for routine xenograft production.Microbial testing for newly and routinely qualified tissue vendors such as porcine, bovine,and equine pericardial tissues.Bioburden testing with different product lines from critical care, vascular system, heart valve therapy, pecutaneous heart valve, percutaneous valve intervention.EO sterilization cycle lot verifications.

  • Regulatory Affairs Research Associate

    Jul 2005 - Jun 2007

  • Quality Assurace Microbiology Technician

    Jun 2003 - Jun 2005
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  Kimberly clark

  Jun 2007 - Sept 2014

  Sr. sterilization quality analyst

  Perform annual Ethylene Oxide Sterilization Validations and RevalidationsExecute quarterly Gamma Radiation dose auditsManage the calibration database system. Assure timeliness and adherence to calibration schedules and equipment.Analyze sterilization results in accordance with FDA/ISO/EN guidelines.

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  Halyard health

  Oct 2014 - Jun 2018

  Halyard Health, formerly Kimberly-Clark

  • Technical Quality Leader I - Sustaining Engineering

    Nov 2014 - Jun 2018

  • Senior Quality Engineer- Sterility Assurance & Laboratory Controls

    Oct 2014 - Sept 2017
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  Avanos medical

  Jul 2017 - Aug 2020

  Technical quality leader- sustaining engineering & sterility assurance
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  Philips

  Aug 2020 - now

  Manager supplier quality assurance