FMA Consulting, LLC - Houston, TX since Sep 2012
President-Owner
Millar Instruments, Inc. - Houston, Texas Area Jul 2008 - Aug 2012
Director of Quality and Regulatory Affairs
Cincinnati Sub-Zero Products Inc. - Cincinnati Area Jul 2007 - Jul 2008
Director of Quality and Regulatory Affairs
Delphi Medical Systems - Houston, Texas Area Jun 2004 - May 2007
Quality and Regulatory Affairs Manager/Senior Quality Engineer
Plastomer Technologies, EnPro Industries - Houston, Texas Area Aug 2000 - Jun 2004
Quality Manager
Education:
Delaware State University 1995 - 1996
Assiut University 1978 - 1982
BS, Electrical Engineering
Skills:
Medical Devices ISO 13485 CAPA QSR Regulatory Affairs Quality Assurance Process Validation Continuous Improvement Regulatory Submissions Design Control Product Development Compliance Process Improvement Lean Manufacturing Biotechnology CE marking Risk Management Process Engineering Strategic Planning FMEA SPC Problem Solving Document Management Process Development cGMP practices Medical Device-Clinical Evaluation ISO 9001 Quality Management system ASQ-Certified Quality Auditor Quality System V&V Iso 9000 Quality Management Process Simulation Validation ISO FDA GMP Six Sigma Engineering Supplier Quality Root Cause Analysis Sop Software Documentation Quality Control Change Control
Interests:
medical device opportunities in quality and regulatory consulting.
Fatma Othman Ali (born September 28, 1950) is a Member of Parliament in the National Assembly of Tanzania. She is a member of the ruling Chama Cha Mapinduzi ...