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Kevin Majka is a Quality Systems and Regulatory Engineer at JALEX Medical, LLC. Since joining JALEX in 2012, Kevin has worked with both large and small clients in developing complex regulatory, quality, and manufacturing solutions for medical devices. At JALEX, he provides services in development, implementation, and remediation of quality management systems compliant to FDA requirements, ISO 13485, and ISO 9001, as well as lead program management activities and writing pre-market notifications. Prior to joining JALEX, Kevin worked at Team Wendy in Cleveland as a Quality Engineer for their military contracted products. Kevin has a B.S. in Biomedical Engineering from Case Western Reserve University and a Quality Engineer Certification (CQE) from American Society for Quality (ASQ).