Accomplished, certified (CMQ/OE), and acknowledged goal-oriented leader with a comprehensive background in process management, supplier development, adverse event reporting, regulatory compliance; regulatory/ISO audits/assessments preparation, and facilitation for various quality management systems. Extensive multi-industry experience within R&D, Operations, Customer Support, Technical Service, Field Service, Laboratory Operations, Manufacturing and Supplier Development processes, and functions. Utilizing strong innovative leadership and management skills; along with proven expertise in training and staff development and strategic planning to enhance the overall business profile. Experienced in Quality Management Systems development, deployment, remediation, auditing and assessing against FDA 21CFR, 211, 820, ISO13485, ISO 9001, AS9100, CLIA/CAP, Food Safety, MBNQP and AS requirements using excellent interpersonal skills, with proficiency in cultivating professional relationships and implementing best practices to develop highly effective business programs.Developing simple, systematic and sustainable systems, processes and training programs that ensure the alignment of the overall strategy of the organization with its business objectives and the local community.A dedicated, results-oriented team player with strong interpersonal, communication, analytical and problem-solving skills experienced in the development and deployment of strategic and tactical initiatives that cultivate positive relationships and strategic alliancesSpecialties:  Quality Management Systems Regulatory Compliance Customer Satisfaction Process development/improvement Complaint Handling  Management Change Strategic planning/analysis Project/process management Risk Management / HACCP QMS Development & Remediation  Team Leadership Training & Skill Development EDGE process utilization Auditing & Assessment IFS PacSecure/Food Safety