Goode Consulting International

Description

Located in: Miramar Town CenterAddress: 11606 City Hall Promenade #204, Miramar, FL 33025 Hours: Open now · Add full hours Unable to add this file. Please check that it is a valid photo. Phone: (954) 399-7510: Hours: Category: : : Place name: Website: : : : Website: http://goodecompliance.com/ Category: Engineering consultant Suggest an editUnable to add this file. Please check that it is a valid photo. Unable to add this file. Please check that it is a valid photo. · Own this business?Add missing informationAdd business hours Unable to add this file. Please check that it is a valid photo. Questions & answers Ask a questionBe the first to ask a question Add a photoThanks for sharing!Your photo will be posted publicly on Google.Contribute MoreDoneUpload public photos of Goode Compliance International Posting publicly on the Web Write a review Reviews Be the first to review

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Goode Consulting International Employees

Employee
Years
Job
Industry
Carlos Carballosa Carlos Carballosa Miami, Florida Details
Carlos Carballosa's Goode Consulting International Experience 2011 - 2013
Job Ph.D. Candidate at University of Miami
Industry Medical Devices
Experience
University of Miami  August 2012 - Present
Goode Consulting International   2011 - 2013

Skills
Clinical Research, Quality Engineering, Cell Culture, Stem Cell Research, Matlab, AutoCAD, Microsoft Office, Spanish-English, Spanish-speaking, Spanish, Biomedical Engineering, In Vitro, Biomaterials, Quality Control, Stem Cells, Cell, Microsoft Excel, Medical Devices, Data Analysis, PowerPoint, Microsoft Word, LabVIEW, Research

Education
University of Miami   2012 — 2018
Doctor of Philosophy (PhD), Bioengineering and Biomedical Engineering

University of Miami   2010 — 2012
Master of Science (M.S.), Bioengineering and Biomedical Engineering

University of Miami   2006 — 2010
Bachelor of Science (B.S.), Bioengineering and Biomedical Engineering

Andrew Joseph Andrew Joseph Greater New York City Area Details
Andrew Joseph's Goode Consulting International Experience August 2013 - May 2014
Job Consultant at Capgemini Consulting
Industry Management Consulting
Experience
Capgemini Consulting  June 2015 - Present
BD  December 2014 - June 2015
Stryker  July 2014 - December 2014
Johnson & Johnson  May 2014 - July 2014
Goode Consulting International   August 2013 - May 2014
STD MED  June 2012 - August 2013
Mercer  December 2010 - June 2012
STD MED  May 2011 - August 2011

Skills
Customer Service, Quality Assurance, Medical Devices, FDA, Product Development, Lean Manufacturing, Strategic Planning, Solidworks, Validation, Biomedical Engineering, R&D, Matlab, Manufacturing, Microsoft Office, Quality System, V&V, ISO 13485, Testing, Design Control, CAPA, SolidWorks

Education
University of Miami   2008 — 2012
Bachelor of Science (BS), Biomedical/Medical Engineering

Janae McFadden Janae McFadden Greater Chicago Area Details
Janae McFadden's Goode Consulting International Experience January 2014 - February 2015
Job Quality Engineer
Industry Medical Devices
Experience
Goode Consulting International   January 2014 - February 2015
Goode Consulting International   October 2013 - December 2013
Beckman Coulter, Inc  November 2011 - September 2013
Medtronic Inc  August 2010 - May 2011
Hallmark Cards Inc  May 2009 - August 2009
Hallmark Cards  May 2008 - August 2008

Skills
FDA, Kaizen, Manufacturing, Medical Devices, Product Development, Solidworks, Root Cause Analysis, Pro Engineer, FMEA, Lean Manufacturing, Manufacturing...

Education
University of Florida   2006 — 2011
Bachelor of Science (B.S.), Mechanical Engineering

David Amor David Amor Minneapolis, Minnesota Details
David Amor's Goode Consulting International Experience January 2010 - August 2011
Job FDA regulatory/ quality expert M Health entrepreneur. SME: design controls, combo products, risk mgmt, mobile health
Industry Medical Devices
Experience
MEDgineering Inc. & MyQuickConsult   January 2008 - Present
ReMind Technologies LLC   June 2013 - Present
St. Cloud State University  April 2015 - Present
University of Minnesota  August 2011 - August 2012
Boston Scientific  May 2010 - August 2011
Goode Consulting International   January 2010 - August 2011
University of Miami Department of Biomedical Engineering   January 2011 - May 2011
University of Miami, Miller School of Medicine  August 2007 - December 2008

Skills
Solidworks, Matlab, Six Sigma, Pro/Engineer, Machining, Intellectual Property..., Strategic Business, Professional Networking, ISO 13485, ISO 14971, Risk Management, Quality Auditing, Quality Assurance, Design for Manufacturing, CAPA, Taguchi, Design of Experiments, Design Verification, Design Validation, Supplier Quality, Endosurgery, Complaint Analysis, Complaints Management, Team Leadership, Medical Devices, FDA, FMEA, R&D, Quality Control, Product Development, Design Control, Regulatory Submissions, CE marking, Remediation, Quality Management, Quality System, Regulatory Affairs

Education
University of Minnesota-Twin Cities   2012 — 2016
Doctor of Philosophy (PhD), Mechanical Engineering

University of Miami   2009 — 2010
MSBE, Biomedical Engineering

University of Miami   2005 — 2009
BS, Biomedical Engineering

old school

old school

Tamar Thompson-Francis Tamar Thompson-Francis Miami/Fort Lauderdale Area Details
Tamar Thompson-Francis's Goode Consulting International Experience 2011 - Present
Job Quality Engineer at Goode Consulting International
Industry Research
Experience
Goode Consulting International   2011 - Present
Florida International University  August 2010 - December 2010
Florida International University  August 2009 - April 2010
Barry University  August 2001 - December 2004
Barry University  August 2003 - April 2004
Medical Associates Hosptial   May 2000 - August 2000

Skills
Solidworks, Medical Devices, Matlab, Research, Photoshop, Biomedical Engineering, Six Sigma, FDA, GMP, Quality Assurance, 21 CFR Part 11, Quality System, ISO 13485

Education
Barry University
Chemistry

Florida International University
Engineering, Biomedical Engineering

Jenna DeFrancesco Jenna DeFrancesco Indianapolis, Indiana Details
Jenna DeFrancesco's Goode Consulting International Experience March 2010 - May 2010
Job Chief Biomedical Engineer at Department of Veterans Affairs
Industry Government Administration
Experience
Department of Veterans Affairs  October 2013 - Present
Advanced Healthcare Technology Solutions   December 2012 - Present
Department of Veterans Affairs  May 2012 - October 2013
Department of Veterans Affairs  June 2010 - May 2012
Goode Consulting International   March 2010 - May 2010
University of Miami  July 2009 - May 2010

Skills
Biomedical Engineering, Microsoft Office, Healthcare Information..., Medical Imaging, Matlab, Project Management, Healthcare, Medical Devices, FDA, Data Analysis, Program Management, PACS, Clinical Research, Hospitals, Biomaterials, Radiology, Digital Imaging, Ultrasound, Informatics, Hardware Diagnostics, Cardiology, HL7, MRI, Medical Technology, EHR

Education
University of Miami
Master of Science, Biomedical Engineering

University of Miami
Bachelor of Science, Biomedical Engineering, Electrical Engineering Concentration

AnnaBethlehem Romulus AnnaBethlehem Romulus Greater Minneapolis-St. Paul Area Details
AnnaBethlehem Romulus's Goode Consulting International Experience March 2010 - January 2012
Job at
Industry Medical Devices
Experience
Smiths Medical  June 2015 - Present
St. Jude Medical  January 2012 - June 2015
Goode Consulting International   March 2010 - January 2012
Abbott Vascular  March 2010 - December 2011
American Medical Systems  2011 - 2011
Boston Scientific  2010 - 2010
Beckman Coulter  October 2007 - October 2009

Education
Florida International University
BS, Biomedical Engineering

James Mullaly, ASQ CQE, CQA James Mullaly, ASQ CQE, CQA Dayton, Ohio Area Details
James Mullaly, ASQ CQE, CQA's Goode Consulting International Experience January 2006 - January 2008
Job Manager, Quality, Manufacturing at NuVasive
Industry Medical Devices
Experience
NuVasive  April 2015 - Present
NuVasive  March 2014 - April 2015
NuVasive  September 2011 - March 2014
Biomet 3i  September 2009 - September 2011
US Spine  April 2007 - September 2009
Goode Consulting International   January 2006 - January 2008
Boston Scientific  January 2006 - April 2007
GE Aviation  May 2005 - August 2005
GE Aviation  May 2004 - August 2004

Skills
V&V, ISO 13485, Medical Devices, Six Sigma, Quality System, FDA, Design of Experiments, CAPA, Minitab, Design Control, Validation, Lean Manufacturing, ISO 14971, Root Cause Analysis, FMEA, Continuous Improvement, Quality Assurance, DMAIC, SPC, Quality Management, Manufacturing, GMP, ISO, Quality Auditing, Biomedical Engineering, Manufacturing..., Supplier Quality, Quality Control, Design for Manufacturing, Cross-functional Team..., Process Capability, CQA, 21 CFR, CQE, Gage R&R, Kaizen

Education
University of Miami   2002 — 2006
BS, Biomedical Engineering, Mechanical Engineering

Mount Hebron High School   1998 — 2002

Kevin Nella Kevin Nella Miami, Florida Details
Kevin Nella's Goode Consulting International Experience June 2014 - June 2015
Job Student at University of Miami Leonard M. Miller School of Medicine
Industry Medical Devices
Experience
Goode Consulting International   June 2014 - June 2015
Joint Bioengineering and Endourological Developmental Surgical Laboratory   August 2012 - May 2014
Nella Consulting, Inc   January 2008 - August 2011
Potbelly Sandwich Works  June 2010 - August 2010
Glenbrook Hospital  August 2009 - June 2010

Skills
Biomedical Engineering, Matlab, Microsoft Office, PowerPoint, Microsoft Word, Microsoft Excel, Healthcare, Research, Teamwork, Medical Imaging, Data Analysis, Medical Devices, C++, Customer Service, Public Speaking, Solidworks

Education
University of Miami Leonard M. Miller School of Medicine   2015 — 2019
Doctor of Medicine (M.D.)

University of Miami   2010 — 2014
Bachelor of Science (BS), Biomedical/Medical Engineering

Oakton Community College   2011 — 2011
EMT-B

Arlesa Hubbard Arlesa Hubbard Greater Boston Area Details
Arlesa Hubbard's Goode Consulting International Experience February 2014 - December 2014
Job Risk Management Engineer at Fresenius Medical Care North America
Industry Medical Devices
Experience
Fresenius Medical Care  December 2014 - Present
Goode Consulting International   February 2014 - December 2014
University of Miami  January 2012 - December 2012
University of Miami  September 2008 - December 2012
Greater Baltimore Medical Center  August 2009 - August 2012

Skills
ISO 13485, ISO 14971, 21 CFR 820, Biomedical Engineering, Biomechanics, Customer Service, Microsoft Office, FDA, Design Control, Matlab, Minitab

Education
Northeastern University   2013 — 2015
Master of Science (M.S.), Regulatory Affairs for Drugs, Devices, and Biologics

University of Miami   2008 — 2012
Bachelor of Science (BS), Biomedical Engineering

Matthew Bontrager Matthew Bontrager San Francisco Bay Area Details
Matthew Bontrager's Goode Consulting International Experience September 2010 - November 2012
Job
Industry Medical Devices
Experience
Heartflow, Inc  November 2012 - Present
Goode Consulting International   September 2010 - November 2012
University of Miami, Biomedical Engineering Dep't   July 2010 - December 2010
Engineering World Health  June 2007 - August 2007

Skills
ISO 13485, Medical Devices, Validation, Quality Assurance, Quality System, GMP, Risk Management, Project Management, CAPA, Leadership, Test Method Validation, Root Cause Analysis, Data Analysis, Process Validation, Process Improvement, Design Control, Python, MySQL, Calibration

Education
University of Miami   2004 — 2010
Master of Science, Biomedical Engineering

University of Miami   2004 — 2010
Bachelor of Science, Biomedical Engineering

Mathieu Joseph Mathieu Joseph Canton, Ohio Area Details
Mathieu Joseph's Goode Consulting International Experience October 2011 - September 2013
Job Quality Engineer at Zimmer Surgical
Industry Medical Devices
Experience
Zimmer Biomet Surgical   September 2013 - Present
Northeastern University College of Professional Studies  2014 - 2015
Goode Consulting International   October 2011 - September 2013
BioNucleonics, Inc   April 2011 - October 2011
Engineering Resources   January 2011 - August 2011

Skills
Biomedical Engineering, Design Control, Medical Devices, Minitab, FDA, CAPA, Design of Experiments, Solidworks, Quality System, Matlab, Validation, FMEA, GMP, Statistics, Lean Manufacturing, 21 CFR, ISO, SPC

Education
Northeastern University   2014 — 2015
Master's Degree, Regulatory Affairs for Medical Devices, Pharmaceuticals, and Biologics

Florida International University   2008 — 2011
Bachelor of Science (BS), Biomedical Engineering

Miami Dade College   2006 — 2008
Associate of Arts (AA), Biology/Biological Sciences, General

Oscar Cumpiano Oscar Cumpiano Milwaukee, Wisconsin Details
Oscar Cumpiano's Goode Consulting International Experience September 2013 - October 2014
Job Quality Engineer I at Goode Consulting International
Industry Biotechnology
Experience
Goode Consulting International   September 2013 - October 2014
Red Arrow Camp  June 2008 - August 2013
Biomaterials Lab, University of Miami   January 2012 - May 2012
Red Arrow Camp  June 2006 - August 2007

Skills
Biomedical Engineering, Biomaterials, Medical Devices, Bioengineering, Biomechanics, Cell Culture, Medical Imaging, Biotechnology, FDA, Matlab, Labview, ImageJ, Design Control, ISO 13485, Lifesciences, Biomedical Devices, ISO 14971

Education
University of Miami   2008 — 2013
Bachelor of Science, Biomedical Engineering

Christina Vangeloff Christina Vangeloff Greater Seattle Area Details
Christina Vangeloff's Goode Consulting International Experience 2009 - 2011
Job Design Quality Engineer
Industry Medical Devices
Experience
Physio-Control, Inc.   January 2014 - Present
Hospira  January 2013 - December 2013
Stryker Instruments  July 2011 - December 2012
Goode Consulting International   2009 - 2011

Skills
Design Control, ISO 14971, V&V, CAPA, ISO 13485, FDA, Medical Devices, Quality System, Validation

Education
University of Miami   2005 — 2009
BS, Biomedical Engineering (Mechanical Concentration)

Guensley Jerome Guensley Jerome Pompano Beach, Florida Details
Guensley Jerome's Goode Consulting International Experience October 2011 - May 2013
Job Teacher at Broward College
Industry Medical Devices
Experience
Broward College  June 2014 - Present
Goode Consulting International   October 2011 - May 2013
Broward College  March 2006 - October 2011
Florida International University  August 2010 - December 2010
Florida International University  August 2010 - December 2010
Florida International University  August 2008 - May 2010
The Fresh Market  August 2006 - August 2007

Skills
Minitab, Six Sigma, Microsoft Office, Microsoft Excel, Validation, Matlab, PowerPoint, Biomedical Engineering, Microsoft Word, Statistics, Medical Devices, Python, R, Maple, Design of Experiments, Excel, Fluent French, SAS Programming, SAS

Education
Florida International University   2007 — 2010
Bachelor, Mathematics

Broward College   2005 — 2006
Associates of Science, Civil Engineering

CNDPS   1997 — 2003

Sarah Boodram Sarah Boodram Miami/Fort Lauderdale Area Details
Sarah Boodram's Goode Consulting International Experience January 2012 - February 2014
Job Quality Engineer II at Goode Consulting International
Industry Biotechnology
Experience
Goode Consulting International   January 2012 - February 2014
Zimmer  2011 - 2014
Zimmer  2011 - 2014
Zimmer  2011 - 2014
Zimmer  2011 - 2014
Zimmer  2011 - 2014
Goode Consulting International   April 2011 - December 2011
Florida International University  September 2008 - April 2009
FIU  September 2008 - April 2009
Florida International University  June 2008 - August 2008

Skills
Biomedical Engineering, Statistics, FDA, Medical Devices, Validation, Laboratory, Matlab, Minitab, ISO 13485, V&V, CAPA, ISO 14971, GMP, Quality System, FMEA

Education
Florida International University   2004 — 2010
Bachelor of Science (B.Sc.), Biomedical/Medical Engineering

Florida International University   2004 — 2010
Bachelor of Science, Biomedical Engineering

Dulce Lacson, CQE, CSSBB, CSSGB Dulce Lacson, CQE, CSSBB, CSSGB Miami/Fort Lauderdale Area Details
Dulce Lacson, CQE, CSSBB, CSSGB's Goode Consulting International Experience January 2012 - April 2012
Job Scientist II, Technical Services at Aveva Drug Delivery Systems
Industry Pharmaceuticals
Experience
Aveva Drug Delivery Systems  September 2012 - Present
Mark Two Engineering  May 2012 - August 2012
Goode Consulting International   January 2012 - April 2012
Boston Scientific  June 2004 - December 2011
LIGHTCONNECT, INC   June 2000 - December 2002
E-Tek Dynamics, San Jose, CA   January 2000 - May 2000
KOBE Precision, Inc.   July 1988 - December 1999

Skills
Manufacturing..., CAPA, CQE, Medical Devices, Six Sigma, Continuous Improvement, ISO, Manufacturing, Engineering, Product Transfer, Gage R&R, Process Capability, Validations, Process Validation, DOE, Quality Engineering, Measurement System..., QSR, Minitab, FMEA, SPC, DMAIC, Root Cause Analysis, FDA, Lean Manufacturing, Quality Control, Quality System, Design of Experiments, Quality Management, Process Simulation, Validation, ISO 13485, V&V, Process Improvement, Design for Manufacturing, Design Control, Product Development, Iso 9000, ISO 14971, ISO 9000

Education
National University
BS, INDUSTRIAL ENGINEERING

Ekta (Nagar) Patel Ekta (Nagar) Patel Tampa/St. Petersburg, Florida Area Details
Ekta (Nagar) Patel's Goode Consulting International Experience May 2008 - July 2008
Job Systems Specialist 1 at Tampa General Hospital
Industry Hospital & Health Care
Experience
Tampa General Hospital  June 2013 - Present
Tampa General Hospital  June 2011 - May 2013
Mount Sinai Medical Center  January 2010 - May 2011
Health Systems Institute   January 2009 - December 2009
Goode Consulting International   May 2008 - July 2008
University of Miami Miller School of Medicine  July 2007 - May 2008
Goode Consulting International   March 2006 - August 2006

Skills
Healthcare Information..., Epic Systems, EHR, Healthcare, EMR, Hospitals, Visio, Medical Devices, Informatics, Project Management, Ambulatory, Inpatient, CPOE, Training, Data Analysis, Healthcare Consulting, Process Improvement, Leadership, Troubleshooting, Software Implementation

Education
Georgia Institute of Technology   2009 — 2009
M.S., Health Systems

University of Miami   2004 — 2009
B.S., Biomedical Engineering

Nicholas Napoli Nicholas Napoli Miami/Fort Lauderdale Area Details
Nicholas Napoli's Goode Consulting International Experience March 2006 - January 2007
Job Graduate Research Assistant at University of Virginia
Industry Medical Devices
Experience
University of Virginia  August 2012 - Present
MetamorPhysics   January 2010 - Present
Miller School of Medicines Department of Neurology   October 2008 - March 2010
University of Miami  January 2005 - June 2009
Goode Consulting International   March 2006 - January 2007
Intelligent Hearing Systems  May 2006 - August 2006
Miller School of Medicine: Department of Biophysics and Physiology   May 2005 - April 2006

Skills
Matlab, Biomedical Engineering, Image Processing, Digital Signal..., Signal Processing, Data Analysis, Molecular Biology, C++, Healthcare, Analytics, Sensor Fusion, Cell, FDA, Statistics, Algorithms

Education
University of Virginia   2013 — 2017
Doctor of Philosophy (PhD), Systems and Information Engineering

University of Miami   2010 — 2012
M.S., Electrical and Computer Engineering

University of Miami   2003 — 2008
B.S.E.E., Electrical and Computer Engineering

University of Miami   2003 — 2008
B.S., Applied Physiology

Cynthia Crespo Cynthia Crespo Tampa, Florida Details
Cynthia Crespo's Goode Consulting International Experience November 2011 - July 2013
Job Medical Student at Morsani College of Medicine
Industry Hospital & Health Care
Experience
Goode Consulting International   November 2011 - July 2013
Florida International University  August 2010 - May 2011
Florida International University  August 2010 - May 2011
Harvard University  June 2010 - August 2010

Skills
Matlab, Cell, Biomedical Engineering, ISO 14971, ISO 13485, Design Control, Medical Devices, Minitab, Solidworks, Microsoft Excel, Laboratory, Cell Culture, Statistics, V&V, FDA, Quality System, FMEA

Education
University of South Florida   2013 — 2017
Doctor of Medicine (MD), Medicine

Florida International University   2006 — 2011
Bachelor of Science, Biomedical Engineering

Eric Steinman Eric Steinman Pompano Beach, Florida Details
Eric Steinman's Goode Consulting International Experience May 2014 - August 2014
Job Research Assistant at University of Florida
Industry Mechanical or Industrial Engineering
Experience
University of Florida  March 2015 - Present
University of Florida  November 2014 - March 2015
Goode Compliance International  December 2014 - December 2014
Goode Consulting International   May 2014 - August 2014
University of Florida  November 2013 - April 2014
Self-employed  December 2011 - May 2013
STaRS— Florida   June 2011 - July 2011

Education
University of Florida   2013 — 2017
Chemical Engineering, Chemical Engineering, GPA— 3.7

North Broward Preparatory School   2004 — 2013

Carlos Baerga Carlos Baerga Tampa/St. Petersburg, Florida Area Details
Carlos Baerga's Goode Consulting International Experience May 2014 - August 2014
Job Post Market Vigilance Consultant at Covidien
Industry Medical Devices
Experience
Covidien  June 2015 - Present
Philips  February 2015 - May 2015
Synthes  September 2014 - December 2014
Goode Consulting International   May 2014 - August 2014
Jabil  March 2011 - April 2014
ASO LLC  January 2009 - November 2010
Teva Pharmaceuticals  January 2002 - August 2007
Noven Pharmaceuticals  2005 - 2007
Biogen  1997 - 2000
ALZA Corporation  1994 - 1997

Skills
Quality Assurance, Quality System, FDA, Quality Management, V&V, Manufacturing, Software Documentation, Training, Root Cause Analysis, Management, Leadership, Project Management, CAPA, Continuous Improvement, GMP, Process Improvement, Quality Auditing, Quality Control, Six Sigma, Medical Devices, Auditing, Pharmaceutical Industry, Change Management, Risk Management, Validation, Change Control, 21 CFR Part 11, Cross-functional Team..., ISO 13485

Education
Southern Illinois University, Carbondale   1991 — 1995
Bachelor's Degree, Industrial Technology/Technician

Cacique Agueybana

Michael Jakubowski Michael Jakubowski Sanford, Florida Details
Michael Jakubowski's Goode Consulting International Experience June 2007 - November 2008
Job Senior Quality Engineer at Covidien
Industry Medical Devices
Experience
Covidien  December 2012 - Present
Kelly Services  January 2012 - September 2012
HeartWare Inc  January 2012 - September 2012
Boston Scientific  June 2011 - October 2011
Boston Scientific  February 2011 - June 2011
Boston Scientific  December 2008 - February 2011
Goode Consulting International   June 2007 - November 2008

Skills
Medical Devices, Quality System, CAPA, Quality Assurance, Design Control, FMEA, Quality Control, Cross-functional Team..., Manufacturing, Engineering, Validation, Six Sigma, Product Development, Calibration, V&V

Education
University of Miami   2004 — 2008
Bachelor of Science (B.S.), Biomedical/Medical Engineering

Anthony Carra, PMP, CSSBB Anthony Carra, PMP, CSSBB Warsaw, Indiana Details
Anthony Carra, PMP, CSSBB's Goode Consulting International Experience February 2012 - August 2012
Job Structured Problem Solving | Continuous Improvement Specialist
Industry Medical Devices
Experience
Zimmer Biomet  July 2015 - Present
Indiana Tech  January 2014 - Present
Business Improvement Group Consulting, LLC   June 2011 - Present
Zimmer  December 2013 - July 2015
Zimmer  August 2013 - December 2013
Medical Engineering Consultants   August 2012 - August 2013
Goode Consulting International   February 2012 - August 2012
Zimmer  February 2012 - August 2012
Boston Scientific  June 2010 - January 2012
ASG Medical Systems   October 2009 - June 2010

Skills
Six Sigma, Lean Manufacturing, Manufacturing, Minitab, Problem Solving, Root Cause Analysis, DOE, Quality Engineering, Design of Experiments, FMEA, Validation, Medical Devices, Design Control, SPC, Continuous Improvement, Process Improvement, Process Control, Kaizen, Statistics, CAPA, Statistical Sampling, Sampling Plans, ISO 13485, 21 CFR 820, Project Management, MS Project, PMP, Lean Operations, Lean Tools, Quality Management, GMP, Quality System, Quality Assurance, FDA, V&V, 5S, Process Capability, ISO, Automation, Process Engineering, Business Process..., Quality Auditing, ISO 14971, Root Cause Problem..., Collaboration, Value Stream Mapping, Black Belt, DMAIC, Gage R, Manufacturing...

Education
New Jersey Institute of Technology (NJIT)   1995 — 2000
BS, Electrical Engineering

National Education Center, RETS Campus   1992 — 1993
CET Certificate, Computer Electronics Technology

New Jersey Institute of Technology   1991 — 1992
BS, Electrical Engineering

Clifton High School   1987 — 1991
Diploma

Penn State University
Master's degree, Applied Statistics

Nicholas Gonzalez, CQE CQA Nicholas Gonzalez, CQE CQA Miami/Fort Lauderdale Area Details
Nicholas Gonzalez, CQE CQA's Goode Consulting International Experience March 2010 - September 2013
Job Staff Quality Assurance Engineer NPD at Beckman Coulter
Industry Medical Devices
Experience
Beckman Coulter  December 2013 - Present
Axiom Quality Group Inc   March 2010 - December 2013
Goode Consulting International   March 2010 - September 2013
Florida Power & Light  June 2007 - March 2010
Goode Consulting International   May 2006 - January 2007

Skills
Process Validation, Quality Assurance, Quality Engineering, Quality Management, Risk Management, Risk Assessment, Failure Modes, AutoCAD, Minitab, Statistics, ISO 14971, ISO 13485, GMP, CAPA, Validation, Quality System, V&V, Medical Devices, Six Sigma, FMEA, Gage R&R, Test Methodologies, Project Management, Certified Quality..., Design of Experiments, ISO, Quality Control, DMAIC, Root Cause Analysis, FDA, Design Control, Testing

Education
HBX Harvard Business School   2014 — 2015
CORe : Credential of Readiness", Pass with Honors

University of Miami   2002 — 2007
Bachelor of Science, Mechanical Engineering

Marianne Grunwaldt Marianne Grunwaldt Miami/Fort Lauderdale Area Details
Marianne Grunwaldt's Goode Consulting International Experience August 2004 - June 2005
Job Quality Assurance Manager
Industry Medical Devices
Experience
Stryker Neurovascular  2012 - 2013
Micrus Endovascular  November 2009 - August 2012
Micrus Endovascular (originally Micrus Design Technology)   December 2007 - November 2009
Micrus Design Technology (originally VasCon LLC)   June 2005 - December 2007
Goode Consulting International   August 2004 - June 2005
FDA CDRH ODE DCD   January 2004 - August 2004
Goode Consulting International   June 2003 - January 2004
University of Miami  1998 - 2004
Sintea Biotech   April 2001 - June 2003

Skills
Medical Devices, Six Sigma, Manufacturing, Lean Manufacturing, ISO 13485, FDA, CAPA, Quality System, Design Control, V&V, Quality Assurance, Validation, FMEA, Biomedical Engineering, ISO, Regulatory Affairs, R&D, Product Development, Minitab, Process Improvement

Education
University of Miami College of Engineering   1998 — 2004
BSBE & MSBE, Biomedical Engineering

Miami Killian Senior High   1994 — 1998

Florida International University
Lean Six Sigma Certificate

Anand Xavier Anand Xavier Irvine, California Details
Anand Xavier's Goode Consulting International Experience March 2004 - September 2006
Job Principal Quality Engineer at St. Jude Medical
Industry Medical Devices
Experience
St. Jude Medical  July 2014 - Present
Boston Scientific  June 2008 - July 2014
Boston Scientific  September 2006 - June 2008
Goode Consulting International   March 2004 - September 2006
Ultra-Scan Corporation  March 2002 - August 2003

Skills
ISO 13485, Design Control, CAPA, V&V, Medical Devices, FDA, ISO 14971, Design of Experiments, Quality System, Minitab, Biomedical Engineering, 21 CFR, Validation, Root Cause Analysis, Supplier Quality, Six Sigma, Quality Assurance, SPC

Education
University of Massachusetts at Amherst - Isenberg School of Management   2012 — 2014
Master of Business Administration (MBA), Operations Management and Supervision

University of Miami   2004 — 2006
Masters, Biomedical Engineering

University at Buffalo   2001 — 2003
Masters, Electrical Engineering

Bharathiar University   1997 — 2001
Bachelor of Engineering (B.E.), Electronics and Instrumentation Engineering

Ebony (Daniels) Sanon Ebony (Daniels) Sanon Miami/Fort Lauderdale Area Details
Ebony (Daniels) Sanon's Goode Consulting International Experience May 2011 - May 2012
Job Business Development Manager and Quality Engineer at BioTeknica
Industry Medical Devices
Experience
BioTeknica  January 2015 - Present
BioTeknica  October 2012 - Present
FDA  May 2012 - September 2012
Goode Consulting International   May 2011 - May 2012
Florida International University  June 2010 - May 2011
NASA Goddard Space Flight Center  May 2009 - August 2009
Texas Instruments  2001 - 2002

Skills
Electrochemical..., X-Ray Diffraction, Cell Culture, Matlab, Contact Angle Meter, Medical Devices, Impedance Spectroscopy, Biomedical Engineering, Validation

Education
Florida International University   2008 — 2012
Master of Science, Biomedical Engineering

Howard University   1996 — 2001
Bachelor of Science, Mechanical Engineering

Kellon Mohan Kellon Mohan Greater Atlanta Area Details
Kellon Mohan's Goode Consulting International Experience 2006 - 2008
Job RD&E Product Development at Ecolab
Industry Research
Experience
Ecolab  April 2014 - Present
Procter & Gamble  April 2010 - March 2014
Procter & Gamble  June 2008 - April 2010
Goode Consulting International   2006 - 2008

Skills
Design of Experiments, Minitab, FMEA, Validation, Biomedical Engineering, Root Cause Analysis, Quality Systems, Medical Devices, ISO, Process Validation, Matlab, Quality Assurance, R&D, Pro/Engineer, Product Development, FDA, V&V, ISO 13485, Quality System, Manufacturing, Cross-functional Team...

Education
University of Miami   2003 — 2008
Bachelor of Science (B.S.), Bioengineering and Biomedical Engineering

Sandhya Bhagwandin Sandhya Bhagwandin San Francisco Bay Area Details
Sandhya Bhagwandin's Goode Consulting International Experience February 2006 - January 2010
Job Quality Engineer at IOGYN
Industry Medical Devices
Experience
IOGYN a Boston Scientific Company   June 2014 - Present
Boston Scientific  January 2010 - Present
Goode Consulting International   February 2006 - January 2010
Purdue University  May 2005 - August 2005

Skills
Design Control, Biomedical Engineering, ISO 14971, ISO 13485, Medical Devices, CAPA, FDA, Validation, V&V, Minitab, Sop, Six Sigma

Education
University of Miami   2004 — 2007
Bachelors, Biomedical Engineering

Margarita Shaposhnikov Margarita Shaposhnikov Miami/Fort Lauderdale Area Details
Margarita Shaposhnikov's Goode Consulting International Experience September 2010 - September 2012
Job Quality Engineer at Goode Consulting International
Industry Medical Devices
Experience
Goode Consulting International   September 2010 - September 2012

Skills
Design Control, Biomedical Engineering, ISO 13485, Medical Devices, V&V, Laboratory, Cell, ISO 14971, CAPA, FDA, Root Cause Analysis

Education
Florida International University
BS, BIOMEDICAL ENGINEERING

Ahmed Hirani (Jimmy) Ahmed Hirani (Jimmy) Miami, Florida Details
Ahmed Hirani (Jimmy)'s Goode Consulting International Experience March 2010 - March 2014
Job Quality Engineer
Industry Medical Devices
Experience
Goode Consulting International   March 2010 - March 2014

Skills
Minitab, Microsoft Project, Microsoft Visio, Microsoft Office 2010, FMEA, MS Project, Quality Control, Visio, Validation, V&V, Medical Devices

Education
University of Florida   2005 — 2009
Bachelors, Civil Engineering

University of Florida   2005 — 2009
Bachelor of Science (B.S.), Civil Engineering

Angela Santos Angela Santos Miami, Florida Details
Angela Santos's Goode Consulting International Experience October 2010 - June 2011
Job Analyst at Bayview Asset Management, LLC
Industry Mechanical or Industrial Engineering
Experience
Bayview Asset Management, LLC  March 2014 - Present
TracFone Wireless  June 2013 - January 2014
Auxis  January 2013 - March 2013
Beckman Coulter  November 2011 - December 2012
Goode Consulting International   October 2010 - June 2011
University of Miami  August 2006 - May 2010
Cordis  May 2008 - August 2008
JRD and Associates, Industrial Engineers, Management Consulting   June 2007 - August 2007

Skills
Six Sigma, Minitab, Visio, Manufacturing, Lean Manufacturing, Solidworks, Process Improvement, Microsoft Excel, FMEA, Matlab, Data Analysis, MS Project, Microsoft Word, Business Objects, Management Consulting, Business Process..., Quality Assurance, Industrial Engineering, Software Documentation, Microsoft PowerPoint, Microsoft Access, Microsoft Project, Microsoft Visio, Rockwell Arena..., Spiral: Logistics CAD, Consulting, Business Process Mapping, Data Mining, Databases, SAS, SQL, CAPA, Analysis, PowerPoint, Process Engineering, Training, Root Cause Analysis, Medical Devices, Statistics, Quality Control, Visual Basic, Design of Experiments, Access, SPC, Testing, Continuous Improvement, Oracle E-Business Suite, Noetix WebQuery, Engineering, FDA

Education
University of Miami   2006 — 2010
Bachelor of Science, Industrial Engineering

Kepner-Tregoe   2008 — 2008
Kepner-Tregoe Training on Problem Solving and Decision Making

Konstantinos Sebekos Konstantinos Sebekos Miami/Fort Lauderdale Area Details
Konstantinos Sebekos's Goode Consulting International Experience November 2011 - Present
Job Biomedical/Quality Engineer
Industry Medical Devices
Experience
Goode Consulting International   November 2011 - Present
Jackson Memorial Hospital  December 2010 - January 2012
FIU: Laboratory of Vascular Physiology and Biotransport   August 2008 - July 2011
Stanford University School of Medicine  June 2009 - August 2009

Skills
Microsoft Excel, Microsoft Office, Matlab, Solidworks, Research, Problem Solving, Minitab, ISO 13485

Education
Florida International University   2005 — 2010
Bachelor of Science (BS), Biomedical Engineering

Smit Pandya Smit Pandya Warsaw, Indiana Details
Smit Pandya's Goode Consulting International Experience January 2012 - January 2013
Job Senior Manufacturing Engineer at Zimmer
Industry Medical Devices
Experience
Zimmer - Trauma  January 2014 - Present
Zimmer Trauma  January 2013 - Present
Goode Consulting International   January 2012 - January 2013
Florida International University: Applied Research Center  January 2010 - December 2011
Florida International University  October 2008 - January 2010

Skills
Manufacturing..., Engineering, Lean Manufacturing, Medical Devices, Minitab, Process Engineering, Design of Experiments, Design Control, Simulations, AutoCAD, Biomedical Engineering, CAPA, Cleaning Validation, FDA, Test Validation, FDA GMP, IQ / OQ / PQ, Six Sigma, Process Flow, Manufacturing Techniques, Quality System, Validation, Manufacturing, ISO 13485, Process Improvement

Education
Florida International University   2008 — 2011
Master's degree, Mechanical Engineering, 3.8

Florida International University   2009 — 2011
Professional Robotics Certification, Mechatronics, Robotics, and Automation Engineering

Gujarat University   2004 — 2008
Bachelors in Mechanical Engineer, Design and Automation, 3.70