1. PAUL J. MIDURA
3771 EAST JASPER DRIVE – GILBERT, ARIZONA – 85296
MR.PAUL2012@GMAIL.COM – 480.275.0752
OVERVIEW
Detail–oriented technical professionalwith B.S. in Bioengineering; FDA CFR 820; ISO 13485; cGMP; DFMEA
and PFMEA risk management activities; Design History File experience; Sales-engineering accomplishments;
MiniTab, Infinity QS SPC, Excel, Outlook, PowerPoint, Visio and Word software proficiency; Cross-functional
team mindset; Clean-room manufacturing experience; Gauge R&R studies
EDUCATION
 Arizona State University
Biomedical Engineering,B.S.E. – Tempe, Arizona (May 2008)
CERTIFICATIONS
 Certified Pharmacy Technician, CPhT
Arizona State Board of Pharmacy – T022994 (Valid through October 31, 2016)
Pharmacy Technician Certification Board (PTCB) – 10085933 (Valid through July 31,2017)
 ISO 13485 Internal Auditor: Medical Device Quality Management Systems
British StandardsInstitution (October2014)
PROFESSIONAL EXPERIENCE
Quality Engineer – Auer Precision – Mesa, Arizona (August 2014 – October 2014)
 Participated in client meetings outlining manufacturing needs and production costs
 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
 Active in manufacturing operations in an effort to identify equipment settings for production
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 stent graft and angioplasty product lines
 Wrote and executed manufacturing procedures,inspection procedures, and Gauge R&R studies
 Utilized complaint files of marketed products to identify potential origin of device/design failure
Senior Intervention Specialist – Express Scripts – Tempe, Arizona (December 2010 – December 2011)
 Managed resolution of rejected insurance claims for the Department of Defense
 Participated in 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)
 Trained pharmacy technicians for multiple locations
 Resolved rejected insurance claims for retail operations
 Managed medication inventory,returns, expiration, and forecasting for business outlook
Account Manager – Lost Sheep Coffee Company – New Orleans, Louisiana (October 2008 – January 2010)
 Business to business sales of whole bean coffee to local cafes, restaurants,and grocery/retail locations
 Initiated promotional efforts for active sampling at grocery stores,farmer’s markets, and restaurants
 Responsible for price negotiation, whole-bean production estimates, and product distribution