Eric Bohne (Work) Email & Phone Number

Social Circle, Georgia

Greater Atlanta Area

Greater Atlanta Area

Quality system management representative and compliance advisor for the Elmira plant. Performed quality system assessments of Synthes US and European manufacturing facilitiesto FDA, ISO 13485, ISO 9001, MDD and CMDR requirements. Performed quality assessments of new and existing suppliers.Worked with suppliers to resolve FDA warning letter issues.Primary liaison with ISO and FDA investigators for the Elmira Plant.Coordinated audit CAPA actions and quarterly management reviews. Participated on Lean process improvement teams.

Performed internal audits to device regulations. Performed audits of suppliers and third party manufacturers.Implemented the transition to ISO 13485:2003 and CMDCAS for enteral feeding tube and pumpmanufacturing facilities.Maintained technical files and CE marking for enteral feeding tubes.Primary liaison with ISO auditors.Managed prep room during FDA audits.Supported device recall activities.Manager, Device QA Managed compliance and supplier quality programs, including staff of four.  Transferred ethylene oxide sterilization responsibilities from former division to local manufacturing facilities, including validation and setup of procedures/program.Manager, Compliance Assurance  Managed internal audit and supplier audit programs, including two auditors. Lead and implemented the transition from ISO 9001/EN46001 to ISO 13485 and Canadian CMDCAS requirements for enteral feeding pumps and tubes. Lead and managed a group of three temp. employees to implement over fifty new corporate policies into site policies and procedures in a six month period. Supported device recall activities, including preparation of customer notifications, FDA notifications and reports and recall reconciliation.Project Leader  Created and implemented an internal audit program for QS regulation and ISO 9001 compliance. Lead ISO 9001/EN46001 implementation team and achieved ISO registration and CE Marking for enteral feeding tubes.

Managed quality assurance activities for cGMP/Quality System Regulation compliance.(internal audits, nonconforming product, failure investigations corrective actionprograms, training)Coordinated product recalls and FDA recall communications.Developed and taught new employee and annual quality systems training.Reviewed customer complaints and lead complaint investigation teams.Represented Quality Assurance on Validation Review Board and Design Review board.Represented company with FDA investigators during inspections.

Administered Document Control system and corrective action programs.Organized and performed training ( GMP-QSR, ISO 9000, Safety).Represented company with FDA, ISO, OSHA, and EPA investigators