Tony Demarinis

About Tony Demarinis

I have extensive knowledge in FDA and ISO Quality Management Systems including managing programs for Auditing, CAPAs, Process Validation, Risk Analysis, Training and Strategic Planning. I led 6 facilities to achieve and maintain certification to ISO 13485. I also have extensive background in Sterilization, Clean Rooms, High Purity Water Systems, Aseptic Processing and other microbiological issues. I am an ASQ Fellow and have a MS in Quality Management and ASQ certifications for CQA, CBA, CMQ/OE, CSSBB and CPGP. I am semi-retired but enjoy being a consultant and training others, determining the Root Cause of system failures and Improving processes.

Experience

1. Training Instructor Quality Management Auditing

   Asq - World Headquarters

   Jan 1993 — Present

   Develop and deliver refresher courses for CQA and CMQ/OE certification programs as well as seminars on Cost of Quality, Root Cause Analysis and Process Improvement.

Education

• Anna Maria College

  MS, Quality Management

  1994 — 1995

• Penn State University

  BS/BS, Biology & Microbiology

  1971 — 1976

Skills

• Iso
• Fda
• Tqm
• Calibration
• Lean Manufacturing
• Continuous Improvement
• Sterilization
• Regulatory Affairs
• Design Control
• Cleaning Validation
• Controlled Environments
• Medical Devices
• Capa
• Iso 9000
• Quality Control
• Gmp
• Mammalian Cell Culture
• Iso 14001
• Kaizen
• Quality System
• V&V
• Root Cause Analysis
• Biocompatibility
• Fmea
• Validation
• 5s
• Change Control
• Microbiology
• Minitab
• Six Sigma Black Belt
• Cqa
• Quality Management
• Dmaic
• Operational Excellence
• Quality Assurance
• Spc
• Value Stream Mapping
• Process Improvement
• Supplier Quality
• Iso 14971