Experience in implementing and sustaining local and global quality systems in the food/beverage and medical device industries. Quality and Program management leader who strategizes/executes continuous improvement initiatives for product quality/quality system opportunities at plant/local, divisional  and corporate levels. Management Representative and point of contact for External & third party Quality Audits Experienced in process and new product transfers using Design Control guidelines and process validationsContinually refines tools and administers programs to enhance the quality system and seeks out best practices that leads to improve customer focus and quality processes within the organization and with suppliers. Effective managerial leadership and direction for Quality Assurance teams through quality training, individual development, feedback and coaching.Specialties: Six Sigma Black Belt CertifiedLead Quality System AuditorProcess ValidationsProject ManagementRisk management  Continuous and System Improvements (including kaizen and lean)Supplier DevelopmentCAPA and failure investigationMedical Device:FDA(21 CFR Part 820), ISO13485, DOT, JPAL, TPED, CMDR, MDD (Medical Device Directive)  and other regulatory experienceFood & Beverage: ISO 22000HACCP ISO 9001