SunMed LLC since Dec 2009
Quality Assurance/Regulatory Affairs Manager
Alfa Wassermann Nov 2005 - Jan 2010
Document & Records Management Supervisor
Rhein Medical Jun 2009 - Sep 2009
Consultant
Education:
Montclair State University 2007 - 2009
University of Economy 1993 - 1997
Skills:
Medical Devices Fda Quality Assurance Cross Functional Team Leadership Validation Quality System Management Iso 13485 Regulatory Affairs Capa Quality Management Process Improvement Pharmaceutical Industry V&V Gmp Quality Auditing Manufacturing Design Control Iso U.s. Food and Drug Administration Technology Transfer Spc Fmea Sop Dmaic R&D 21 Cfr Part 11 Iso 14971 5S Supplier Quality Corrective and Preventive Action Business Process Improvement Research and Development Verification and Validation
Interests:
Children Economic Empowerment Education Environment Science and Technology Disaster and Humanitarian Relief Arts and Culture Health
Languages:
English
Certifications:
Healthcare Informatics Lean Six Sigma Master Black Belt