Thomas Fuller

Background

About Thomas Fuller

Hands on entrepreneurial executive with 15 years medical device quality, engineering, and manufacturing experience. Skilled in corporate strategy, medical device manufacturing and quality systems (QMS), continuous improvement, root cause analysis, risk analysis, ISO and FDA standards. Seasoned leader with strong organizational and prioritization abilities. Areas of Expertise: • Operations and Scheduling • Process Improvement • Lean Manufacturing and SPC Statistical Process Control • Global CAPA - Corrective Action Preventative Action • REACH / RoHS • FDA CFR Title 21 • ISO 13485, ISO 9001 • GxP: GMP, GDP, GLP, GCP • Supplier Quality Management • Med Device Clinical trials (IRB) • QMS Quality Management Systems • Clean Room manufacturing • Sterile Manufacturing • New Product Research & Development • Intellectual Property development and management • Black Belt equivalent statistics • Medical Device Industry & Business Development • Medical Device Manufacturing & Development • Injection and Blow Molding • Strategic Quality Planning and Alignment • Manufacturing Operations • Leadership and Supervision • Value Stream Analysis • Solidworks • Class I, II, Medial Device • Risk Management • IVD products • Root Cause Analysis • Micro-fluidics