Experienced Quality Professional with a demonstrated history of working in the medical device manufacturing industry. Skilled in, Microsoft Office, Manufacturing, High Level Of Accuracy, and Teamwork. Strong quality assurance professional with a Associate's degree focused in Marketing from Gateway Technical College. Knowledgeable in GDP, GMP , LEAN and Kaizen workshops. FDA Regulatory Audits and Medical Component Qualification.Experience working in a highly regulated, FDA and ISO certified environment. Class I, II, III medical device manufacturing. SPIAQ, Plastic injection molding, ISO 13458 cleanroom experience as well.