Brad Vawter

WORK HISTORY

EDUCATION

SKILLS

ABOUT BRAD VAWTER

RocheI am proud to work at Roche Diabetes Care. We have excellent high quality products, strong quality management systems, great co-workers, and a sustainable culture to maintain profitability and drive continuous improvement into the future. The primary projects I am focused on to move us to the next level is improving our SPC systems, strengthening our quality management system, innovating our regulatory compliance systems, and using data to improve and drive our maintenance activities and process improvements. Beckman Coulter• Actively maintaining and continually improving process and validation documentation for over 30 unique processes.• Championed Lean improvements to reduce process WIP time from 30 minutes to 8 minutes with an annual savings over $50K.• Developed and implemented new re-commercialization process including Build of Materials (BOM), routing, work instruction and complete process validation strategy from initiation through completion. Boston Scientific Accomplishments• Designed and implemented new skive mandrels within FDA regulated environment while reducing consumable cost by 70% and scrap by 80%.• Led group designing and prototyping new Sphincter Tome wrapping fixture to be implemented in Q4 of 2010 to improve customer quality and value.• Experienced at writing and executing an attribute test method validation protocol (ATMV) to validate a pressure decay test method.• Identified and corrected multiple areas needing clarification within complex process validation documentation, including Master Validation Protocols/Reports (MVP/R)Specialties: • Strong communication skills to improve the work environment.• Troubleshooting advanced process and equipment problems to root cause using a systematic process.• Lean Manufacturing, TPM and TPS• Design for Manufacturing and Assembly (DFMA)• 20 years of CAD experience using SolidWorks• FEA analysis experience using SolidWorks Simulation