M Squared Associates
Regulatory and Quality
Aesculap Implant Systems, Inc. Nov 2005 - Oct 2013
Manager, Qa
Encore Medical 1991 - 2002
Qa and Ra Manager
Intermedics Ortho Sulzermedica 1982 - 1991
Qa Manager
Carbomedics 1983 - 1985
Project Engineer
Education:
The University of Texas at Austin 1977 - 1982
Bachelors, Bachelor of Science
Skills:
Fda Iso 13485 Medical Devices Design Control Quality Assurance Quality System Capa Gmp Iso Validation Quality Auditing R&D Manufacturing Surgical Instruments Ce Marking V&V Orthopedic Iso 14971 Quality Management Process Simulation Orthopedics Regulatory Affairs 21 Cfr Commercialization Sterilization Fda Gmp Fmea Change Control Aseptic Processing Iso 9000 Sop Pma Glp Software Documentation