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Quality Assurance Engineer Resume

OBJECTIVE
Seeking challenging work as Engineer with a focus on development, implementation, and evaluation of engineering activities, including but not limited to qualification, verification and validation, compliant processing, quality system investigations and product issues with advance knowledge of statistics, engineering, and science.

EXPERIENCE

Confidential– Quality Assurance Engineer Nov. 2011 – Present Developed work instructions, process validations, equipment validations, FMEAs, CAPAs and analytical methods validations. Took part as the quality team member in the development of a new medical device to ensure that the device was in accordance with customer and FDA compliance. Used statistical methods, ISO standards, CFRs, and FDA regulations to improve, diagnose, and develop quality control practices.

Confidential– Research and Design Intern May 2011 –Nov. 2011 
Assisted the director of product development in research while also solving physical, chemical, and biological issues by designing and implementing experimental protocols that lead to a more fundamental understanding of material and product properties. Worked closely with manufacturing during upscale of a new product transitioning from R&D to manufacturing.

Confidential– Project Manager/Team Leader Jan. 2011 – Dec. 2011
Designed/prototyped and delivered a low cost multi-functional hospital bed for all hospital needs in low resource countries that have limited/no access to quality medical equipment to decrease death or injury rates due to low quality equipment. A testing protocol and operations manual was also developed.

Confidential– Lead Researcher Sept. 2010 – June 2011 
Physical and chemical properties of biodegradable polymer electrospun nanofiber scaffolds were studied to determine the likelihood that cardiac cells could migrate and differentiate into cardiac tissue and survive in the human body in hopes of repairing dead cardiac tissue of patients that have suffered from a myocardial infarction. Identified new and unique combinations of polymers that could be electrospun into nanofiber scaffolds that would allow cells to migrate and differentiate into tissue.

EDUCATION
Confidential University 
Bachelor of Science, Biomedical Engineering, 
*Most Outstanding Engineer Honors*

COMPUTER SKILLS
MS Office®, SolidWorks®, Minitab®, MS Project®, QI Macros®, SAP®, MatLab®, LabView®

PROFESSIONAL AFFILIATIONS
President, Biomedical Engineering Student Organization Jan. 2011 – Present
President, Professional Engineers of North Carolina Student Society Sept. 2008 – Present

VOLUNTEER WORK
Confidential Senior Games 
Confidential Soccer Association Soccer Coach

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