Timothy Cassity

WORK HISTORY

EDUCATION

SKILLS

ABOUT TIMOTHY CASSITY

Over 40 years experience in Sr. Quality Management Systems, Global Internal and External Auditing, ISO/QMS Consulting and Training, primarily in the Medical Device & Department of Defense and Aerospace Industries, such as: Medical Device Class I, II and Electro-Mechanical Systems, Lasers/Optics and Composites. Core competencies include: Total Quality Management Initiatives, Quality System Design and Remediation, Global Quality Systems & Regulations Compliance. Organizational Leadership, Strategic Planning, & Project Management.As part of FDA mandated Consent Decree, Responsible for providing gap assessments, problem statements, containment activities, root cause analysis, corrective action plans for several major findings within the companies quality audit, CAPA and NCR processes and procedures. The project scope consisted of retrospective review of all 483’s, warning letters, An effective, passionate, results-oriented leader with over three decades of dedicated holistic quality management system experience. Experienced leader with a proven track record of achieving breakthrough results through a thorough and practiced understanding of the key elements of the quality system. Extensive “hands on” experience in conducting Medical Device CAPA root cause investigations and complaint investigations using Six Sigma DMAIC methodologies. For example: Heart & Lung Machines, 767 Aero Medical Hospitals, Blood Gas Analyzers, Medical Device X-Ray Systems, MRI units for Hospitals as well as NASA’s Space Shuttle External Tank.Certified in TQM, and has received formal Black Belt training from GE’s Six Sigma Principle Corporate Trainer, Scott Lasater, while holding an executive position with the Lasater Institute.