Karen Tran Chien, CQIA

14717 Thatcher Drive Austin, Texas 78717

karentchien@gmail.com 512.264.5426

EDUCATION
2004 2008 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

2012 2014 KINETIC CONCEPTS, INC. SAN ANTONIO, TX
Negative pressure wound therapy
CAPA Engineer II (November 2012 July 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 2012 November 2012)
Distribute employee training on CAPA Processes
Update board meetings and prepare monthly metrics
Coordinate CAPA review, tracking and filing

2007 2011 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 Skills: List any business specific/technical skills. (Such as SPSS, NPV, Monte Carlo, Java, MRP, C and C++ Programs, etc.)
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