Senior Manager with thirty-two years of extensive experience in the Medical Device field.  Strong skill set in Quality Assurance and Regulatory Affairs with ASQ and CQM certifications.

Titles Held: Director of QA/RA; Quality & Regulatory Manager; Quality Services Manager; Quality Assurance Manager; Clinical Laboratory Supervisor

• Qualified in Regulatory activities including 510(k) submissions, foreign country product registrations, product device master records, and EU MDD technical file maintenance
• Extensive experience with implementing Quality Systems compliant with FDA (QSR) and applicable regulatory standards such as MDD 93/42/EEC, ISO 13485, FCC, RTTE, and EMC requirements
• Experience in process and equipment validation including processes in EtO and Gamma Sterilization
• Effectively implemented a plant-wide ISO-9000 certification which resulted in certification by BSI to EN 29001 and EN 46001
• Strong experience with Electromechanical, Mechanical, Electronics, and Capital Equipment