Timothy Budacki

overview

Mr. Budacki is an executive business consultant with wide knowledge of domestic and global enterprise risk management and product safety. He has worked with over two hundred medical device companies. Mr. Budacki has extensive experience developing product safety programs for medical device manufacturers integrating medical device risk management with established quality and regulatory compliance standards. Areas of expertise include:

- Product Safety and Enterprise Risk Management
- Human Factors Engineering and Ergonomics
- Risk Assessments for Medical Products
- Word Control, Warnings, Instructions, Standard Operating Procedures
- Vision, Communication through Management Alinement
- Product Safety techniques for New Product Design

He holds specialty certifications from:

- International Board of Certified Safety Managers
- Maritime Safety Institute, Clearwater, Floridia: Industrial Hygiene & Toxicology
- Institute for Safety & Health Management
- The Academy of Board-Certified Environmental Professionals
- Aetna Casualty & Surety, Hartford, Certification, Insurance and Risk Management
- Advanced Ergonomic & Human Factors Training: University of Wisconsin
- Concepts & Principles of Process Validation, Stat-A-Matrix
- Design Controls for Medical Device Manufacturers, Excel Partnership, Inc.

Awards

- Medrad/Bayer “Spirit Award” quality, work life, teamwork , esprit de corps.
- Malcolm Baldridge National Quality Award , two-time team member awards.