Michael Thomas Email & Phone Number

Orlando, FL, US

Orlando, Florida Area

Orlando, Florida Area

Consulted for Fortune 500 medical device corporations to improve quality system compliance.

Developed automated root cause analysis tool, and provided CAPA and quality systems improvement to medical device companies.

Responsibility for all quality processes in blood collections and manufacturing operations for fourth largest blood banking organization in US, with operations in northern Illinois and western Pennsylvania. Developed CAPA system and improved all quality processes for ITxM.

Developed all quality systems for Class III device manufacturer.

Pittsburgh, PA

Responsibilities included all quality system support for the organization, including Manufacturing and New Product Development at three manufacturing locations in Pittsburgh, PA, Atlanta, GA, and Bend, OR.

Durham, NC

Promoted in July 2003 to top quality assurance position at corporate North America headquarters, which included manufacturing operations for IVD devices & Biologics. Developed all new quality system processes to make significant improvements in the organization.

Chicago, IL

Responsible for all global quality systems and functions for RTC.

Despite continuous FDA inspections, no FDA 483 notifications were issued in the 14 years under my responsibility. Responsibilities included direction of Manufacturing and Product Development Quality Engineering, Quality Audit, FDA Interface, Regulatory Submission Support, Customer Satisfaction, Document Control and CAD Groups, Global Product Quality.