Quest Diagnostics-Nichols Institute Diagnostics
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Quest Diagnostics-Nichols Institute Diagnostics Employees
Randstad September 2014 - Present
Siemens Healthcare January 2011 - July 2014
Siemens Healthcare May 2009 - January 2011
Siemens Healthcare January 2007 - May 2009
Siemens Healthcare April 2006 - January 2007
Quest Diagnostics, Nichols Institute Diagnostics September 2002 - April 2006
Skills
FDA, Hardware Diagnostics, GMP, Lifesciences, Clinical Research, Biotechnology, Quality Control, Quality Assurance, Pharmaceutical Industry, Medical Devices, Quality System, R&D, Product Development, Infectious Diseases, ISO 13485, Validation, Sop, Healthcare, V&V, Process Improvement, CAPA, Regulatory Affairs, Oncology, Laboratory, Microbiology, Clinical Trials, Life Sciences, SOP
Education
University of Alabama at Birmingham 1996 — 2002
PhD, Medical Genetics
University of Alabama at Birmingham 1995 — 1996
BS, Biology
University of Alabama at Birmingham 1991 — 1995
BA, Philosophy
Consulting Services March 2012 - Present
SEDLine, Inc. / Masimo Corporation December 2009 - March 2012
Extomed, LLC December 2006 - December 2009
Quest Diagnostics - Nichols Institute Diagnostics February 2006 - December 2006
Respironics 2003 - 2006
Applied Medical 1998 - 2003
Medstone International 1994 - 1998
Newport Medical Resources 1988 - 1994
Skills
Medical Devices, Quality Systems, Regulatory Affairs, ISO 13485, FDA, Clinical, 510 K, Validation, Design Control, Manufacturing, QSR, Life Sciences, Compliance, cGMP, ISO, GMP, Quality Assurance, Biotechnology, CAPA, Six Sigma, ISO 14971, Lean Manufacturing, Continuous Improvement, 21 CFR Part 11, SPC, Auditing, Healthcare, Strategic Planning, Start-ups, Cross-functional Team..., FMEA, Process Validation, Orthopedics, GLP, Requirements Analysis, Risk Management, Biomedical Engineering, Clinical Development, Documentation, DMAIC, Analysis, Product Development, PMA, FDA Warning Letter..., FDA 483 Response and..., FDA IDE, Health Canada ITA, Combination Products, Quality System, Quality Control
Education
California State University-Dominguez Hills 1992 — 1994
MS, Quality Assurance
National Institute of Technology Karnataka 1981 — 1985
BSEE, Electrical Engineering
Rajkumar College, Rajkot 1969 — 1981
High School
Enigma Diagnostics February 2014 - Present
BioRad Inc. September 2006 - February 2014
Quest Diagnostics - Nichols Institute Diagnostics September 2000 - June 2006
Beckman Coulter, Inc January 1993 - June 2000
Skills
CAPA, Validation, GMP, FDA, ISO 13485, Medical Devices, V&V, Sop, Biotechnology, Quality System, Change Control, Lifesciences, 21 CFR Part 11, GLP, Quality Assurance, HPLC, Pharmaceutical Industry, ELISA, LIMS, R&D, Six Sigma, ASQ, Technology Transfer, ISO 14971, Quality Auditing, Biochemistry, Immunology, Protein Chemistry, Quality Management, Laboratory, Continuous Improvement, Medical Diagnostics, Chemistry, Lean Manufacturing, Manufacturing, Product Transfer, Process Improvement, 21 CFR, Quality Control, Immunoassays, Chromatography, Testing, Regulatory Affairs, Design Control, Software Documentation, Computer System..., Analytical Chemistry, Biopharmaceuticals, Assay Development, ISO
Education
Univeristy of Phoenix, San Diego 1998 — 2000
MBA, Technology Management
University of California, San Diego 1987 — 1992
Bachelor of Science (BS), Biochemistry/Cellular Biology
Quest Diagnostics, Inc. January 2006 - Present
Quest Diagnostics, Nichols Institute Diagnostics 2006 - Present
Quest Diagnostics, Inc. 1991 - Present
Quest Diagnostics 1991 - Present
Skills
Healthcare Information..., Biotechnology, Quality Assurance, Laboratory Medicine, Clinical Research, Medical Devices, Healthcare
Education
Southern Illinois University, Carbondale 1969 — 1973
Quest Diagnostics, Nichols Institute July 2009 - Present
Quest Diagnostics, Nichols Institute Diagnostics 2006 - 2009
Quest Diagnostics 2003 - 2006
Scripps Clinic 2001 - 2003
The Scripps Research Institute 1994 - 2001
Clarian Health Partners 1988 - 1994
Skills
CLIA, Pathology, Laboratory, Laboratory Medicine, Validation, Flow Cytometry, Clinical Trials, Hematology, Medical Diagnostics, Infectious Diseases, Clinical Research, HIPAA, Healthcare, Coagulation, Immunology, Healthcare Information..., Assay Development, Hospitals, Biotechnology, Lifesciences, 21 CFR Part 11, Quality Assurance, Oncology, Medical Technology, GLP, Cancer, Sop
Education
Purdue University 1987 — 1988
MT (ASCP)
Purdue University 1984 — 1988
BS
taylor high school 1980 — 1984
High School Diploma
Open Doors USA November 2013 - Present
Open Doors USA March 2012 - November 2013
Quest Diagnostics-Nichols Institute August 2006 - February 2008
Quest Diagnostics-Nichols Institute Diagnostics August 2002 - September 2006
Quest Diagnostics-Nichols Institute Diagnostics August 2002 - September 2006
Quest Diagnostics-Nichols Institute Diagnostics July 2002 - September 2006
Quest Diagnostics-Nichols Institute Diagnostics August 2002 - August 2006
Skills
Benefits Administration, Employee Relations, IIPP Development and..., I9 audits, Human Resources, Recruiting, Employee Benefits, New Hire Orientations, Training, Personnel Management, PeopleSoft, Job Descriptions, Policy, Onboarding, Leadership, System Administration, Workforce Planning, Affirmative Action, Talent Management
Education
University of Phoenix 2001 — 2002
B.S., Business Management
Sierra Community College
AA, Early Childhood Development and Education
EMD Millipore November 2005 - Present
Quest Diagnostics - Nichols Institute Diagnostics September 1995 - November 2005
Skills
Biotechnology, Validation, GMP, Quality System, FDA, CAPA
Education
University of California, Riverside 1991 — 1994
Bachelor of Arts (B.A.), Liberal Arts and Sciences/Liberal Studies- Emphasis on Biology