Karen Tran
Medical Device Quality Assurance
Austin, TX
Work Experience
CAPA Engineer II
November 2012 to Present
• Coordinate CAPA review and processing
• Compile CAPA process performance metrics, track and present
• Schedule corporate CAPA review boards
• Support CAPA project teams and communicate with management
• Implement process improvements
CAPA Quality Assurance Associate
March 2012 to November 2012
Coordinate quality training and maintain employee training records; CAPA record tracking; audit preparation against FDA Quality System Requirements (QSR), ISO 13485;
Staff Writer
October 2011 to April 2012
Compose informative articles about the latest biomedical research, technology, and market activities
Engineering Validation Specialist
August 2007 to October 2011
(April 2010 - October 2011)
Created marketing materials: device photos, presentations, fliers, articles and graphics
Recorded design inputs, failure mode error analysis and compiled device documentation for GLP/GMP control
Developed standard operating procedures for validation pre-clinical testing
Researched and maintained knowledge of ocular vaccine technology
(May 2009 - April 2010)
Engineering Support:
Performed experimental data collection and analysis in laboratory and clean-room environments
Managed lab equipment and supplies, parts inspection and cleaning
(August 2007 - May 2008)
Team Leader "Seahorse Versidoser" electro-mechanical drug delivery device:
Collected customer data and evaluated existing technologies
Collaborated in CAD modeling and concept development
Programmed electro-mechanical products and assembled delivery systems
Presented functional prototype for clients
Researcher
May 2007 to May 2008
Tracked cancer cell metastasis in 3D matrices of variable stiffness using aseptic and cell imaging techniques
Maintained CELS@Home distributed computing project website
Researched scientific literature to analyze biotechnology markets in third world countries
Technical Support Receptionist
May 2005 to August 2005
Answered phones and emails; filled work orders; maintained loan equipment; organized software, documents and task schedules
Research Assistant
June 2004 to August 2004
Statistical analysis of disease incidence in the Caspian Basin; generate hypotheses and published article "Central Asian Communicable Disease" in UT Applied Research Labs annual anthology
Education
B.S. in Biomedical Engineering
August 2004 to May 2008
Study Abroad in Gene and Drug Delivery
January 2007
Skills
Microsoft Applications; Excel, Word, Powerpoint, Outlook, OneNote, etc. • Programming MatLAB, C, SPIN code • High Speed Photography, Photoshop • Basic SolidWorks • Biosafety Level 2 Lab Experience • Clean-room experience • Autoclave Techniques • Sonication • Pipette Techniques • FTIR Spectroscopy • High Speed Camera Use • Microscopy • Design of Experimentation • Scientific Literature Research • Technical Writing • Five years of study in French • Conversational Vietnamese • Experience implementing websites
