Experience

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  Rb / schiff nutrition international

  May 2007 - Apr 2012

  Quality assurance
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  Edwards lifesciences

  Jul 2009 - Apr 2012

  Quality engineer

  Process/Product ValidationsTest Method ValidationsIQ, OQ, PQ, PPQNon Conformance ReportsProviding Quality Engineering and Operations Quality support for THV productions and operations that included the transfer of new products and processes to the Draper facilityDaily floor supportFailure investigation (Root Cause Analysis and Corrective Action)Dispositioning non-conforming materialsOptimizing and improving processesData collection and trending of key metrics that includeApplication of Statistical Process ControlAddressing supplier quality issuesValidating new processes and equipmentDefining quality inspection plansConducting risk analysis (Failure Mode Effects Analysis)Optimizing and improving quality systems and procedures for THV operationsApproving Device Master Record changesInterfacing with the Irvine, CA THV team regarding Design Control roll-outs of new products and transfers Show less

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  Icu medical

  Apr 2012 - Jan 2013

  Quality engineer

  -New product development-design control, risk management reports, FMEA, design verification.-Validation of injection molding and automation equipment- IQ, OQ, PQ.-Production support and process improvement.-Customer complaints, root cause analysis.-Writen and conducted verification/validation protocols and reports for new or revised products and components. -Writen product performance specifications and assure that all product specifications define and test for clinically accepted standards as well as compliance to appropriate ISO standards. -Provided Technical support to R&D, Marketing, Design Engineering and Project Management for new product activities including Design Controls and Risk Management. -Actively participated on various project teams providing QE support at the depth commensurate with the project. Show less

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  Stryker

  Jan 2013 - Nov 2014

  Supplier quality engineer

  • Work with internal customers and suppliers in support of supplier development and certification and the establishment of process equivalence.• Provide technical support to internal customers and suppliers for activities related to supplier quality system assessment, performance evaluation, and supplier development.• Responsible for supporting Supplier Development initiatives and for implementing quality related-programs and projects and will serve as liaison between suppliers and operations to drive supplier improvement.• Liaise with internal customers to ensure effective problem resolution. Develop metrics and report. Identify supplier non-conformance trends.• Coordinate and participate in supplier conference calls.• Plan, execute and deliver projects effectively within defined time/cost parameters.• Track supplier quality performance measurements for strategic suppliers.• Support supplier quality management programs such as supplier selection and certification.• Manage, issue, track and trend all audit corrective actions.• Participate in supplier visits and supplier audits.• Manage, track and trend all supplier corrective actions initiated by Operations.• Evaluate and determine the internal requirements for approval of all specific supplier change requests (SCRs).• Work with internal customers in support of supplier certification activities, including skip-lot, product source and reduced inspection requirements.• Lead supplier visits and supplier audits.• Lead and participate in supplier development projects and continuous improvement activities focusing on supplier quality. Show less

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  Edwards lifesciences

  Dec 2014 - Jan 2021

  Quality Engineering Lead Quality Engineering Lead

  • Manager Quality Engineering

    Aug 2016 - Jan 2021

  • Staff Quality Engineer

    Jul 2015 - Jul 2016

  • Senior Quality Engineer

    Dec 2014 - Jun 2015
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  Arthrex

  Feb 2021 - Nov 2021

  Global capa and quality systems manager
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  Medtronic diabetes

  Nov 2021 - now

  Senior manager quality systems