Michael has over 17 years quality related experience in implementing and maintaining ISO 9001 and 13485 standards in FDA regulated manufacturing environments, developing supplier quality initiatives, and a strong background in internal and external auditing, CAPA maintenance, and process improvement. He has an outstanding ability to train and coach Process Improvement Teams while continuously searching for organizational development opportunities.
He has participated in multiple FDA Warning Letter Remediation projects, conducted a variety of internal/supplier audits and gap assessments for ISO certification and MDD.
He is an ISO 13485:2016 Lead Auditor and in the process of receiving his lead auditor certification for ISO 9001:2015.
He has worked for both small start-up organizations to larger corporations such as Thermo Fisher Scientific, Philips Healthcare, and Roche Diagnostics.
He is a US Navy veteran and obtained his MBA from the University of Phoenix.
ISO 13485:2016 Lead Auditor