OVERVIEW
Detail–oriented technical professional with B.S. in Bioengineering; DFMEA and PFMEA risk management activities; Design History File experience; MiniTab, Infinity QS SPC, MS Excel, Outlook, PowerPoint, and Word software proficiency; Cross-functional team mindset; Clean-room manufacturing experience; Gauge R&R studies; FDA CFR 820; cGMP; ISO 13485:2003
EDUCATION
• Arizona State University
Biomedical Engineering, B.S.E. – Tempe, Arizona
• British Standards Institution
ISO 13485:2003 Internal Auditor Certification – Mesa, Arizona
PROFESSIONAL EXPERIENCE
Quality Engineer – Auer Precision – Mesa, Arizona (August 2014 – October 2014)
• ISO 13485:2003 Internal Auditor training and coursework
• Wrote control plans for large scale manufacture of customer designed medical devices
• Wrote operational qualifications for stamping, slitting, and converting systems
• Utilized SPC software for performance analysis of new equipment vs. current processes
Quality Engineer – C. R. Bard – Tempe, Arizona (December 2011 – June 2013)
• Risk-management activities for design reviews; DFMEA and PFMEA
• Utilized FDA design controls in new product development activities
• Wrote and executed IQs, OQs, and PQs for manufacturing and inspection equipment
• Updated Design History Files (DHF) for various medical devices
• Wrote and executed manufacturing procedures, inspection procedures, and Gauge R&R studies
Quality Review Specialist – Express Scripts – Tempe, Arizona (December 2010 – December 2011)
• Managed resolution of rejected insurance claims for the Department of Defense
• Oversaw efforts to minimize DPMO in prescription processing
• Analysis and review of work orders, patient profiles, and processing errors
Supervising Pharmacy Technician – Bashas’ – Tempe, Arizona (January 2010 – December 2010)
• Hired and trained pharmacy technicians for multiple locations
• Resolved rejected insurance claims in retail operations
• Managed medication inventory, returns, expiration, and forecasting for business outlook
Rese...
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