Amgen - Thousand Oaks since Jan 2013
Principal Quality Engineer
Amgen May 2012 - Jan 2013
Global Device Quality
Medtronic Oct 2008 - May 2012
Principal Reliability Engineer/Core Team Leader
Johnson & Johnson (Ethicon Endo-Surgery) - Chihuahua Area, Mexico Sep 2006 - Oct 2008
Manufacturing QE Lead/QS Auditor
Abbott Vascular Devices (Formerly Guidant) Jul 2004 - Sep 2006
Sr.Quality/Process Engineer
Education:
San Diego State University-California State University 2010 - 2013
Master of Science (MS), Regulatory Affairs Science
University of Phoenix 2000 - 2002
MBA, Global Management
Florida International University 1993 - 1996
Bachelors in Science, Chemistry
Miami Dade College 1991 - 1993
Associate of Arts (A.A.), Biology/Biological Sciences, General
Skills:
Fda Iso 13485 Quality System Medical Devices Design Control Validation V&V Capa Gmp U.s. Food and Drug Administration Continuous Improvement Six Sigma Design of Experiments Fmea Quality Control Verification and Validation Cross Functional Team Leadership Lean Manufacturing Iso 14971 Change Management Minitab Iso Risk Management Corrective and Preventive Action Regulatory Affairs Drug Delivery Validations Failure Mode and Effects Analysis Statistics Design For Manufacturing Dmaic Quality Systems Technology Transfer 21 Cfr Part 11 Design For Assembly Lean Sigma Process Validation Drm Spc Teamwork Statistical Sampling Statistical Software Communication
Languages:
English Spanish
Certifications:
Certified Manager of Quality For Org.excellence (Cmq/Oe) Certified Quality Engineer (Cqe) Certified Biomedical Auditor (Cba) Lean Six Sigma Black Belt Certified Six Sigma Black Belt (Cssbb) Train the Trainer Influencing Others License 13494 License 51292 License 426 License 11012
Oct 2008 to 2000 Principal Reliability EngineerETHICON ENDOSURGERY (a medical device J&J Company)
Oct 2006 to Oct 2008 Senior Manufacturing Quality EngineerABBOTT VASCULAR (formerly Guidant) Temecula, CA Jun 2004 to Sep 2006 Sr. Quality Engineer / Team leader - EndovascularCORDIS CORPORATION (a medical device J&J company) Miami Lakes, FL Jun 2002 to Jan 2004 Sr. R&D/Process Engineer-EndovascularELAN CORPORATION Miramar, FL Jun 1996 to Jun 2002 Sr. R&D/Formulation Chemist
Education:
San Diego State University San Diego, CA 2010 to 2012 Masters of Regulatory Affairs ScienceUniversity of Phoenix Plantation, FL 2000 to 2002 MBA in Business Administration, Global ManagementFlorida International University Miami, FL 1994 to 1997 Bachelor of Science in ChemistryMiami Dade Community College Miami, FL 1991 to 1994 Associate of Arts in Biology, Honors Program Graduate
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Leonel Vanegas
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EMPRESA FELVENZA - AUXILIAR (2011)
Leonel Vanegas
Work:
EMPRESA FELVENZA - AUXILIAR (2011)
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