Kathi Muela
Quality Systems Manager
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Kathi Muela serves as Manager of Quality Systems at La Jolla Institute for Allergy & Immunology (LIAI), and is responsible for directing a new initiative to establish a Quality Management System that supports the strategic plans and initiatives of the Institute in the area of business process development and improvement, using various tools including process mapping, document management, process measurement and review, process improvement, and management review.
She leads a focus on business process management by clarifying responsibility and accountability for each identified business process and clearly defining process boundaries. A structured approach to continuous improvement is maintained so that processes can be managed effectively and improved on a continuous basis. Regulatory requirements associated with business processes are identified in order to monitor and ensure compliance.
Prior to joining LIAI in 2009, Kathi has 15 years direct experience successfully implementing and maintaining quality management systems to meet international standards (ISO 9001:2000 or 13485:2003) in regulated industries, including biomedical and power generation. She held the role of ISO Management Representative at multiple organizations, and is a certified lead auditor for both ISO 9001:2000 and ISO 13485:2003 quality management systems. She holds an Advanced Certificate in Biomedical Quality Systems (a masters-level program) from San Diego State University.
