Engineer Quality

Location:

Posted:

July 29, 2014

Michael Troiani

Quality Engineer II - Baxter International Inc

Wheeling, IL

*******.*****@*****.*** - 847-***-****

WORK EXPERIENCE

Quality Engineer II

Baxter International Inc - Round Lake, IL - September 2011 to Present

• Performed post market data analysis on IV solution sets & peritoneal dialysis products

• Completed monthly trending / analysis of complaint data to identify potential product / process issues

• Investigated product and process issues through nonconformity and CAPA investigations

• Evaluated returned product samples to replicate the reported failure

• Created protocols for testing product per specifications

• Monitored complaint data on a weekly basis to ensure information was accurate and consistent

• Executed weekly data export for monitoring timeliness of work performed for the department

• Performed risk reviews in order to determine if escalation was required

• Initiated field corrective action assessments

• Reviewed and verified change packages

• Updated and verified risk documents

• Assisted in preparing and compiling responses to FDA inquiries

Lab aide

University of Illinois at Chicago - Chicago, IL - July 2009 to January 2010

• Tailed, weaned, and managed mice colony

• Prepared tails to extract DNA

• Genotyped mice through PCR and gel electrophoresis

• Prepared reagents

EDUCATION

Bachelor of Science in Bioengineering

University of Illinois at Chicago - Chicago, IL

2006 to 2011

ADDITIONAL INFORMATION

• Proficient in Minitab, Microsoft Excel, Word, and PowerPoint

• Familiar with FDA regulations, ISO standards, MATLAB, Maple, ImageJ, labVIEW, and C++

• Academic experience in constructing operational amplifier circuits, flexure testing biomaterials, designing

and building a custom neck support system for a child with hydrocephalus, and differentiating mesenchymal

stem cells on three-dimensional scaffolds.