Director of Quality, Laboratory Controls Responsible for Quality Control procedures and processes for all clinical laboratories. Ensures full compliance with CLIA and FDA regulations, CAP and ISO standards and New York State Department of Health requirements. 20-years of experience in the clinical laboratory field 10-years of experience in clinical laboratory compliance CLIA Program Manager, State of Utah; brings extensive laboratory auditing and assistance in ensuring laboratories achieve compliance Manager, Utah Department of Public Health Variety of clinical laboratory and compliance roles, ARUP Laboratories Specialties: Public health reporting Laboratory compliance and management Internal/external regulatory audits Technical/SOP writing Education: BS, Biological Science: University of Texas, El Paso Certifications: ASCP

Vice President, Quality Assurance & Regulatory Affairs Responsible for ensuring compliance with U.S. and international Quality Management System regulations and standards and driving efficient FDA and EMA approvals for a series of products under the KidneyIntelX portfolio brand 24-years of experience in senior Quality & Regulatory leadership roles Head of Quality Assurance, Abbott Molecular Diagnostics Worldwide Vice President, Quality Assurance & Regulatory Affairs, Becton Dickinson Global Vice President, Quality Assurance & Regulatory Affairs, CareFusion Education: BS, Biological Science: University of Texas, El Paso Certifications: Lean Six Sigma Black Belt

Head of Clinical Laboratory Operations Responsible for clinical laboratory operation activities across all KidneyIntelX labs Held various leadership roles at Quest Diagnostics, a worldwide provider of IVD diagnostics Held science and technical operation roles, ARUP Laboratories and Labcorp Education: BS, Clinical Lab Science; University of Nebraska Medical Center MBA: University of Utah, David Eccles School of Business Certifications: Six Sigma, ASCP

FAQs Archive - Renalytix

Renalytix uses cookies to improve your experience. We respect your privacy and are committed to protecting your personal data. Read Privacy Notice.

Nancy Heidman

Joseph Hutson

Baljit Singh

Michael J. Donovan PhD, MD

Michael J. Donovan
PhD, MD