Max Baumgartner Email & Phone Number

Max Baumgartner Skills

• Sanitation, Allergen Management, GMP’s, Pest Control, and Hygienic Zoning
• Clean In Place & Clean Out of Place validations
• Project validations and studies to support process control, implant cleanliness
• Project validations & studies for product sterilization, sterility assurance
• Gas Plasma Sterilization process validations for medical device implants
• Steam sterilization process valildations
• Reusable device cleaning & sterilization validations
• Performed sterile product release of terminally implantable medical devices
• Assistant Microbiology Laboratory Supervisor
• Reusable device design specialist with respect to cleanability & sterilization
• Performed gamma irradiation sterilization validations for medical devices
• Participated in Kaizen 5S lean manufacturing activities
• Knowledge of GMP,QSR,USP,ANSI/AAMI/ISO Environmental & Sterilization standards
• Knowledge of ISO 13485 Quality System Regulations
• Knowledge of ISO 14971 App. of Risk Management to Medical Devices
• Food Microbiology experience
• Microbiology
• Quality System
• GMP
• V&V
• Medical Devices
• Validation
• Sterilization
• Quality Assurance
• Laboratory
• Lean Manufacturing
• FDA
• Environmental Monitoring
• ELISA
• CAPA
• ISO 13485
• Design Control
• Verification and Validation V&V
• Sanitation
• Regulatory
• Engineers
• Project Validations and Studies for Product Sterilization
• Sterility Assurance
• Corrective and Preventive Action Capa
• Compliance
• Knowledge of Gmp
• Operations
• Implant Cleanliness
• QSR
• USP
• Clean in Place and Clean Out of Place Validations
• Reusable Device Cleaning and Sterilization Validations
• u.s. Food and Drug Administration Fda
• Regulatory Compliance
• Allergen Management
• Gmps
• Pest Control
• Services
• Hygienic Zoning
• Project Validations and Studies to Support Process Control
• Ansi/Aami/Iso Environmental and Sterilization Standards
• Verification and Validation
• u.s. Food and Drug Administration
• Corrective and Preventive Action