Karen T Chien Resume -- 03SEP2014

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  • 8/11/2019 Karen T Chien Resume -- 03SEP2014

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    Karen Tran Chien, CQIA14717 Thatcher Drive Austin, Texas 78717

    [email protected]

    EDUCATION

    20042008 THE UNIVERSITY OF TEXAS AT AUSTIN, COCKRELL SCHOOL OF ENGINEERING AUSTIN, TX

    Bachelor of Science in Biomedical Engineering - May 2008.

    Women in Engineering Mentor; Micro - Molecular Biology Student Society President; Engineers Without Borders

    Webmaster

    Researched cancer cell metastasis using aseptic and cell imaging techniques for Zaman Lab, UT BME Department

    Published "Central Asian Communicable Disease" in 2004 UT Applied Research Labs Anthology

    Studied "Gene and Drug Delivery" abroad at L'cole Centrale de Lille, France - Summer 2007

    National Merit Corporate Scholar

    EXPERIENCE

    20122014 KINETIC CONCEPTS, INC. SAN ANTONIO, TX

    Negative pressure wound therapy

    CAPA Engineer II (November 2012July 2014)

    Global CAPA system administration and metrics tracking

    CAPA document review and drafting; CAPA team support

    Host to weekly CAPA review boards and communication with management Train personnel on Root Cause Analysis and CAPA procedures

    Auditor to ISO 13485 and 21 CFR 820 standards

    External audit preparation

    CAPA Quality Assurance Associate (March 2012November 2012)

    Distribute employee training on CAPA Processes

    Update board meetings and prepare monthly metrics

    Coordinate CAPA review, tracking and filing

    20072011 MYSTIC PHARMACEUTICALS, INC. AUSTIN, TX

    Ophthalmic and intranasal drug delivery devices

    Engineering Validation Specialist (April 2010 - October 2011)

    Developed standard operating procedures for verification testing Compiled design history files: recorded device inputs, Device Master Record and failure mode error analyses

    Engineering Support (May 2009 - April 2010)

    Performed experimental data collection in laboratory and clean-room environments

    Optimized parts inspection and device assembly

    Managed lab equipment and supplies

    Team Leader, "Seahorse VersiDoser" Ophthalmic/Nasal Drug Delivery Device Project (August 2007 - May 2008)

    Collected customer data and evaluated existing technologies

    Developed concept and CAD model

    Programmed and assembled prototype; presented to clients

    ADDITIONAL INFORMATION

    Employability Status: U.S. Citizen

    Certifications:Certified Quality Improvement Associate, American Society for Quality (Cert. # 9362); RABQSA ISO

    13485 Lead Auditor Trained (Cert. # Q17111); QMS-A Certification Pending

    Memberships: American Society for Quality

    Languages:Conversational Vietnamese

    Skills and Interests:Microsoft Office, Adobe, document control via SharePoint / Oracle / MasterControl,

    Photoshop, WordPress; Foreign Languages, Technical Writing, Scientific Journalism

    REFERENCES

    Humberto Lozoya,KCI Senior Manager Global CAPA Process(210) 515-4147

    Lonnie Lassmann,KCI Senior Director Global Quality Systems(210) 515-4386

    Nadene Mitchell,KCI Senior Manager Complaint Handling(210) 515-4109

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