Brian R. Bowman Email & Phone Number

Dayton, Oh, Us

Dayton, Ohio Area

 Successfully maintains an ISO13485:2016 and FDA/GMP compliant Quality Management System. Has successfully completed ISO13485 audits without a major nonconformance in 14 years of certification. Manages a team of Quality Control Inspectors responsible for final inspection and testing, incoming inspections, and assembly cell audits. Prepares medical device premarket notifications to FDA and Health Canada. Acts as the primary liaison between AmeriWater and regulatory agencies (FDA, Health Canada, City of Dayton, Intertek and UL) during surveillance audits. Prepared submissions for and received 11 Health Canada Medical Device Licenses. Prepared submissions for and received ETL listing for 10 product lines (including UL60601, UL61010, and UL979 standards). Implemented and manages the Environmental Health and Safety program including safety training sessions for all employees and OSHA record keeping. Safety program has achieved over ten years without a lost time incident. Successfully brought the company into compliance with the City of Dayton Wastewater Department and reduced the cost for wastewater discharge permits

Dayton, Ohio Area

 Successfully developed and implemented an FDA/GMP compliant Quality Management System where no system existed previously. Implemented corrections to prior warning letters and brought AmeriWater into compliance with FDA regulations. Acted as the primary liaison between the organization and the FDA. Prepared premarket notification submissions to FDA and obtained marketing clearance for 9 medical devices or medical device families. Developed and presented FDA compliance training for over 50 employees and over 50 dealer organizations. Achieved ISO13485 Certification for AmeriWater. Developed an employee continuous improvement program resulting in a dramatic increase in employee feedback and preventive actions implemented. Certified and responsible for DOT Hazmat (Title 49 CFR) shipping regulations.

 Supervised a team of 11 quality inspectors. Generated defect and performance reports for the Vice President of Operations. Developed and implemented over 20 work instructions in both the quality and assembly departments. Worked in conjunction with engineering and manufacturing supervisors to implement corrective actions for issues encountered within the manufacturing process. Audited product on the assembly line. Conducted calibration tests on tools in manufacturing. Conducted hardware, software, and process audits.

Associate Of Science (A.S.), Computer Science

Completed courses in Statistics and Accounting

Education record

Completed courses in Calculus and Physics