Laboratory Director Of Quality Systems And Regulatory Affairs
Blood Systems
Directs the review and approval of documents (SOPs, training, validations, etc.) and ensures computerized medical and computer applications are in compliance with regulations. Primary contact with all regulating agencies and is responsible for managing the approval and submission of all regulated documents for assigned division. Direct the audit program and analyzes data for improvement. Serves as a resource on quality and regulatory related issues. Actively participates in Six Sigma and other performance improvement initiatives.
Oct 2009 - Jul 2014
