Ken Block Consulting
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Ken Block Consulting Employees
Employee
Years
Job
Industry
Adam Ziegler Adam Ziegler's Ken Block Consulting Experience May 2009 - October 2009
Job Copywriter
Industry Writing and Editing
Experience
Match.com January 2013 - Present
On Hold Media Group October 2009 - June 2012
Ken Block Consulting May 2009 - October 2009
Skills
Copy Editing, Editing, Content Writing, Content Development, Social Media, Proofreading, Copywriting, Newsletters, Content Strategy, Voiceovers, Creative Writing, Voice Over, Magazine Articles, Web Content, Feature Articles
Education
University of North Texas 2005 — 2008
BA, Technical Writing
Match.com January 2013 - Present
On Hold Media Group October 2009 - June 2012
Ken Block Consulting May 2009 - October 2009
Skills
Copy Editing, Editing, Content Writing, Content Development, Social Media, Proofreading, Copywriting, Newsletters, Content Strategy, Voiceovers, Creative Writing, Voice Over, Magazine Articles, Web Content, Feature Articles
Education
University of North Texas 2005 — 2008
BA, Technical Writing
Kuniko Peden Kuniko Peden's Ken Block Consulting Experience
Job Legal & Administrative Coordinator at Richell USA, Inc.
Industry Consumer Goods
Experience
Ken Block Consulting
Skills
Microsoft Excel, Microsoft Office, Microsoft Word, PowerPoint, Research
Education
Tokai University 1979 — 1982
Bachelor's degree, Fine art
Ken Block Consulting
Skills
Microsoft Excel, Microsoft Office, Microsoft Word, PowerPoint, Research
Education
Tokai University 1979 — 1982
Bachelor's degree, Fine art
Cindi Kisiel-Smith Cindi Kisiel-Smith's Ken Block Consulting Experience October 2009 - October 2010
Job Principal Consultant at Cynthia J KisielSmith, Inc
Industry Medical Devices
Experience
Cynthia J Kisiel-Smith, Inc October 2014 - Present
Cynthia J. Kisiel-Smith, Inc. November 2012 - Present
QualityHub, Inc. October 2010 - Present
Cynthia J. Kisiel-Smith, Inc. July 2010 - Present
Ken Block Consulting October 2009 - October 2010
Immucor, Inc. July 2005 - February 2009
BD Diagnostic Systems April 2000 - July 2005
Abbott Laboratories September 1990 - April 2000
Skills
SOP, Quality Assurance, Compliance, Life Sciences, Six Sigma, Microbiology, Environmental Monitoring, Quality Systems, Process Validation, FDA, CAPA, GMP, Validation, Medical Devices, Design Control, Quality Auditing, Quality Management, QSR, Document Management, Regulatory Requirements, Process Improvement, Validations
Education
Texas Tech University 1983 — 1987
BS, Microbiology
Cynthia J Kisiel-Smith, Inc October 2014 - Present
Cynthia J. Kisiel-Smith, Inc. November 2012 - Present
QualityHub, Inc. October 2010 - Present
Cynthia J. Kisiel-Smith, Inc. July 2010 - Present
Ken Block Consulting October 2009 - October 2010
Immucor, Inc. July 2005 - February 2009
BD Diagnostic Systems April 2000 - July 2005
Abbott Laboratories September 1990 - April 2000
Skills
SOP, Quality Assurance, Compliance, Life Sciences, Six Sigma, Microbiology, Environmental Monitoring, Quality Systems, Process Validation, FDA, CAPA, GMP, Validation, Medical Devices, Design Control, Quality Auditing, Quality Management, QSR, Document Management, Regulatory Requirements, Process Improvement, Validations
Education
Texas Tech University 1983 — 1987
BS, Microbiology
Katrina McMillin Katrina McMillin's Ken Block Consulting Experience September 2010 - December 2010
Job Illustrator/Designer
Industry Graphic Design
Experience
Jon Paul's Print Shop October 2012 - Present
Cool Glow June 2011 - August 2011
Ken Block Consulting September 2010 - December 2010
Skills
Graphic Design, Illustration, Web Design, Art, Typography, Logo Design, Art Direction, Illustrator, Layout, Corporate Identity, Posters, Adobe Creative Suite
Education
University of North Texas 2004 — 2009
Bachelor of Arts (B.A.), Communication Design
Jon Paul's Print Shop October 2012 - Present
Cool Glow June 2011 - August 2011
Ken Block Consulting September 2010 - December 2010
Skills
Graphic Design, Illustration, Web Design, Art, Typography, Logo Design, Art Direction, Illustrator, Layout, Corporate Identity, Posters, Adobe Creative Suite
Education
University of North Texas 2004 — 2009
Bachelor of Arts (B.A.), Communication Design
Shen Rong (Shirley) Qiu, CQA, CQE, RAC's Ken Block Consulting Experience October 2009 - October 2010
Job Manager QA at Gilead Alberta
Industry Pharmaceuticals
Experience
Gilead Alberta November 2010 - Present
Ken Block Consulting October 2009 - October 2010
priMED Medical Products Inc. Edmonton October 2006 - September 2009
DELON LABORATORIES (1990) LTD., Montreal September 2004 - August 2006
ENTREPRISE IMPORTFAB INC., Montreal August 2003 - September 2004
JINGLUN ELECTRONIC CO., LTD., Wuhan, China January 1999 - April 2001
RHK GROUP CO., LTD., Wuhan, China February 1997 - January 1999
WUHAN BLOWER WORKS, Wuhan, China July 1988 - January 1996
Skills
Quality System, ISO 13485, FDA, GMP, ISO 9001, ISO14001, Regulatory Affairs, Regulatory Inspections..., ISO
Education
Huazhong University of Science and Technology 1984 — 1988
Bachelor of Engineering, Mechnical Engineering
Gilead Alberta November 2010 - Present
Ken Block Consulting October 2009 - October 2010
priMED Medical Products Inc. Edmonton October 2006 - September 2009
DELON LABORATORIES (1990) LTD., Montreal September 2004 - August 2006
ENTREPRISE IMPORTFAB INC., Montreal August 2003 - September 2004
JINGLUN ELECTRONIC CO., LTD., Wuhan, China January 1999 - April 2001
RHK GROUP CO., LTD., Wuhan, China February 1997 - January 1999
WUHAN BLOWER WORKS, Wuhan, China July 1988 - January 1996
Skills
Quality System, ISO 13485, FDA, GMP, ISO 9001, ISO14001, Regulatory Affairs, Regulatory Inspections..., ISO
Education
Huazhong University of Science and Technology 1984 — 1988
Bachelor of Engineering, Mechnical Engineering
Sakiko (Kaifu) Usami Sakiko (Kaifu) Usami's Ken Block Consulting Experience June 2015 - Present
Job Translator Ken Block Consulting
Industry Translation and Localization
Experience
Ken Block Consulting June 2015 - Present
Diamond Friedman Co., Ltd. June 2013 - Present
Consulate General of the United States of America, Osaka-Kobe June 2005 - November 2005
Consulate General of the United States of America, Osaka-Kobe September 2003 - February 2005
Embassy of the United States of America, Tokyo December 1999 - July 2003
Embassy of the United States of America, Tokyo March 1997 - March 1998
Former Prime Minister Toshiki Kaifu Office April 1995 - August 1996
Education
青山学院大学 / Aoyama Gakuin University 1993 — 1997
Internatinal Politics, Bachelor's degree
Ken Block Consulting June 2015 - Present
Diamond Friedman Co., Ltd. June 2013 - Present
Consulate General of the United States of America, Osaka-Kobe June 2005 - November 2005
Consulate General of the United States of America, Osaka-Kobe September 2003 - February 2005
Embassy of the United States of America, Tokyo December 1999 - July 2003
Embassy of the United States of America, Tokyo March 1997 - March 1998
Former Prime Minister Toshiki Kaifu Office April 1995 - August 1996
Education
青山学院大学 / Aoyama Gakuin University 1993 — 1997
Internatinal Politics, Bachelor's degree
David Manalan's Ken Block Consulting Experience 2009 - 2010
Job Senior FDA and Quality SystemsConsultant
Industry Medical Devices
Experience
INQC Consulting, Inc. January 1992 - Present
ASQ Biomedical Division 1995 - Present
AlvaMed, LLC 2011 - September 2014
ASQ Boston Section September 2008 - May 2011
MassExcellence April 2009 - April 2011
CLSI 2009 - 2011
Ken Block Consulting 2009 - 2010
Barile-Consulting 2007 - 2010
American Society for Quality- FDC 2001 - 2010
SoftwareCPR 2000 - 2009
Skills
ISO 13485, ISO 14971, Quality Systems, FDA, CAPA, CQA, Quality Assurance, Auditing, Pharmaceuticals, Medical Devices, Validation, Process Validation, Quality Auditing, Biomedical Auditing, Teaching Adults, Quality System, V&V, Sustainability, Risk Management, Risk Assessment, Enterprise Risk..., GMP, Pharmaceutical Industry, Regulatory Affairs, Root Cause Analysis, Design Control, Manufacturing, Training, Quality Management, Program Management, Process Improvement, Six Sigma, ISO, Cross-functional Team..., Iso 9000, Sop, 21 CFR Part 11, TQM, Biomedical Engineering, Process Engineering, Change Control, Design of Experiments, R&D, Lean Manufacturing, Continuous Improvement, Biotechnology, SPC, DMAIC, Quality Control, FMEA
Education
Massachusetts Institute of Technology 1961 — 1965
BS, Chem Eng
INQC Consulting, Inc. January 1992 - Present
ASQ Biomedical Division 1995 - Present
AlvaMed, LLC 2011 - September 2014
ASQ Boston Section September 2008 - May 2011
MassExcellence April 2009 - April 2011
CLSI 2009 - 2011
Ken Block Consulting 2009 - 2010
Barile-Consulting 2007 - 2010
American Society for Quality- FDC 2001 - 2010
SoftwareCPR 2000 - 2009
Skills
ISO 13485, ISO 14971, Quality Systems, FDA, CAPA, CQA, Quality Assurance, Auditing, Pharmaceuticals, Medical Devices, Validation, Process Validation, Quality Auditing, Biomedical Auditing, Teaching Adults, Quality System, V&V, Sustainability, Risk Management, Risk Assessment, Enterprise Risk..., GMP, Pharmaceutical Industry, Regulatory Affairs, Root Cause Analysis, Design Control, Manufacturing, Training, Quality Management, Program Management, Process Improvement, Six Sigma, ISO, Cross-functional Team..., Iso 9000, Sop, 21 CFR Part 11, TQM, Biomedical Engineering, Process Engineering, Change Control, Design of Experiments, R&D, Lean Manufacturing, Continuous Improvement, Biotechnology, SPC, DMAIC, Quality Control, FMEA
Education
Massachusetts Institute of Technology 1961 — 1965
BS, Chem Eng
Christian Beeman Dickey Christian Beeman Dickey's Ken Block Consulting Experience January 2014 - March 2015
Job Clinical Engineer Complaint Investigator
Industry Medical Devices
Experience
Cyberonics March 2015 - Present
University of Texas at Dallas August 2013 - Present
Ken Block Consulting January 2014 - March 2015
University of Texas at Dallas January 2014 - May 2014
University of Texas at Dallas August 2013 - December 2013
Legends Sports Complex May 2013 - August 2013
DS Recreational Services May 2012 - August 2013
University of Texas at Dallas January 2013 - May 2013
Skills
Regulatory Affairs, Regulatory Standards, Regulatory Submissions, LabVIEW, Microsoft Office, PowerPoint, Microsoft Excel, Teamwork, Research, AutoCAD, Market Research, Customer Service, Leadership
Education
The University of Texas at Dallas 2011 — 2015
Bachelor of Science (BS), Bioengineering and Biomedical Engineering
Cyberonics March 2015 - Present
University of Texas at Dallas August 2013 - Present
Ken Block Consulting January 2014 - March 2015
University of Texas at Dallas January 2014 - May 2014
University of Texas at Dallas August 2013 - December 2013
Legends Sports Complex May 2013 - August 2013
DS Recreational Services May 2012 - August 2013
University of Texas at Dallas January 2013 - May 2013
Skills
Regulatory Affairs, Regulatory Standards, Regulatory Submissions, LabVIEW, Microsoft Office, PowerPoint, Microsoft Excel, Teamwork, Research, AutoCAD, Market Research, Customer Service, Leadership
Education
The University of Texas at Dallas 2011 — 2015
Bachelor of Science (BS), Bioengineering and Biomedical Engineering
Paige Gridack's Ken Block Consulting Experience May 2015 - Present
Job Regulatory/Marketing Specialist for Ken Block Consulting
Industry Medical Devices
Experience
Ken Block Consulting May 2015 - Present
Heartflow, Inc March 2015 - May 2015
Spinal Elements, Inc April 2011 - October 2014
Spinal Elements, Inc. April 2010 - April 2011
Autopawn of California June 2009 - July 2010
The Law Offices of Thomas W. Rutledge January 2009 - May 2009
The New York City Police Museum January 2008 - December 2008
Skills
Published Author, Microsoft Office 2007, ISO 13485, Auditing, Process Scheduler, Microsoft Office, Medical Devices, FDA, Cross-functional Team..., Research, Product Development, Program Management, Quality System, Six Sigma, Regulatory Submissions, 510(k) Submissions, Certified Lead Auditor
Education
New York University 2007 — 2008
Master of Arts (MA), Archives & Public History
University of California, San Diego 2002 — 2006
Bachelor of Arts (B.A.), US Cultural History
Ken Block Consulting May 2015 - Present
Heartflow, Inc March 2015 - May 2015
Spinal Elements, Inc April 2011 - October 2014
Spinal Elements, Inc. April 2010 - April 2011
Autopawn of California June 2009 - July 2010
The Law Offices of Thomas W. Rutledge January 2009 - May 2009
The New York City Police Museum January 2008 - December 2008
Skills
Published Author, Microsoft Office 2007, ISO 13485, Auditing, Process Scheduler, Microsoft Office, Medical Devices, FDA, Cross-functional Team..., Research, Product Development, Program Management, Quality System, Six Sigma, Regulatory Submissions, 510(k) Submissions, Certified Lead Auditor
Education
New York University 2007 — 2008
Master of Arts (MA), Archives & Public History
University of California, San Diego 2002 — 2006
Bachelor of Arts (B.A.), US Cultural History
Gary Utrup, CMQ/OE Gary Utrup, CMQ/OE's Ken Block Consulting Experience 2009 - May 2015
Job Pharmaceutical Compliance Manager for the Amcor Rigid Plastics Diversified Products Business Unit
Industry Packaging and Containers
Experience
Amcor Rigid Plastics May 2015 - Present
Axeon, Inc. August 2014 - May 2015
Ken Block Consulting 2009 - May 2015
med fusion 2010 - July 2014
Abbott Diagnostics 2000 - 2009
Abbott Diagnostics 1993 - 2000
Abbott Diagnostics 1993 - 1994
Abbott Diagnostics 1987 - 1993
NW Ohio Regional Red Cross 1978 - 1987
Skills
Quality Systems, Compliance Audits, FDA, CAPA, Quality System, Quality Auditing, Recalls, System Deployment, Program Management, Quality Management, Quality Assurance, Medical Devices, Cross-functional Team..., Management, Process Improvement, Laboratory, Change Control, Regulatory Affairs, Lifesciences, Coaching, Training, ISO, Design Control, Team Leadership, Continuous Improvement, Pharmaceutical Industry, Clinical Trials, Project Management, V&V, Six Sigma, Iso 9000, Leadership Development, Biotechnology, Testing, Manufacturing, SDLC, Validation, Leadership, Strategy, GMP, ISO 13485, Strategic Planning, 21 CFR Part 11, Immunoassays, Sop, Quality Control, GLP, Hardware Diagnostics, Microbiology, Process Engineering
Education
Kennedy Western University 2003 — 2006
ASQ Certification CMQ/OE, Master in Quality Program
Bowling Green State University 1985 — 1987
BB(ASCP), Immunohematology for Medical Technologist, SBB Masters Program
University of Toledo 1974 — 1979
Bachelors, Biology
Amcor Rigid Plastics May 2015 - Present
Axeon, Inc. August 2014 - May 2015
Ken Block Consulting 2009 - May 2015
med fusion 2010 - July 2014
Abbott Diagnostics 2000 - 2009
Abbott Diagnostics 1993 - 2000
Abbott Diagnostics 1993 - 1994
Abbott Diagnostics 1987 - 1993
NW Ohio Regional Red Cross 1978 - 1987
Skills
Quality Systems, Compliance Audits, FDA, CAPA, Quality System, Quality Auditing, Recalls, System Deployment, Program Management, Quality Management, Quality Assurance, Medical Devices, Cross-functional Team..., Management, Process Improvement, Laboratory, Change Control, Regulatory Affairs, Lifesciences, Coaching, Training, ISO, Design Control, Team Leadership, Continuous Improvement, Pharmaceutical Industry, Clinical Trials, Project Management, V&V, Six Sigma, Iso 9000, Leadership Development, Biotechnology, Testing, Manufacturing, SDLC, Validation, Leadership, Strategy, GMP, ISO 13485, Strategic Planning, 21 CFR Part 11, Immunoassays, Sop, Quality Control, GLP, Hardware Diagnostics, Microbiology, Process Engineering
Education
Kennedy Western University 2003 — 2006
ASQ Certification CMQ/OE, Master in Quality Program
Bowling Green State University 1985 — 1987
BB(ASCP), Immunohematology for Medical Technologist, SBB Masters Program
University of Toledo 1974 — 1979
Bachelors, Biology
Elena Guinto's Ken Block Consulting Experience August 2009 - April 2010
Job QC Engineer III at Intuitive Surgical
Industry Medical Devices
Experience
Intuitive Surgical May 2013 - Present
C8 MediSensors March 2012 - January 2013
Sonitus Medical Inc. July 2011 - March 2012
Boston Scientific June 2010 - July 2011
Ken Block Consulting August 2009 - April 2010
Reglera August 2009 - April 2010
Boston Scientific, Fremont December 1994 - July 2009
Skills
Minitab, FDA, Six Sigma, Design Control, CAPA, ISO 13485, Design of Experiments, Lean Manufacturing, CE marking, Quality System, Manufacturing, V&V, DMAIC, Validation, Medical Devices, Manufacturing..., ISO 14971, FMEA, Biomedical Engineering, SPC, Root Cause Analysis, R&D, DFMEA, Supplier Quality, 21 CFR Part 11, PFMEA, GMP, Quality Auditing, Design Verification..., Quality Assurance, Change Control, Cross-functional Team..., Design for Manufacturing, Product Development, Quality Control
Education
California Polytechnic State University-San Luis Obispo 1986 — 1991
Bachelor of Science (BS), Industrial Engineering
Philippines
Intuitive Surgical May 2013 - Present
C8 MediSensors March 2012 - January 2013
Sonitus Medical Inc. July 2011 - March 2012
Boston Scientific June 2010 - July 2011
Ken Block Consulting August 2009 - April 2010
Reglera August 2009 - April 2010
Boston Scientific, Fremont December 1994 - July 2009
Skills
Minitab, FDA, Six Sigma, Design Control, CAPA, ISO 13485, Design of Experiments, Lean Manufacturing, CE marking, Quality System, Manufacturing, V&V, DMAIC, Validation, Medical Devices, Manufacturing..., ISO 14971, FMEA, Biomedical Engineering, SPC, Root Cause Analysis, R&D, DFMEA, Supplier Quality, 21 CFR Part 11, PFMEA, GMP, Quality Auditing, Design Verification..., Quality Assurance, Change Control, Cross-functional Team..., Design for Manufacturing, Product Development, Quality Control
Education
California Polytechnic State University-San Luis Obispo 1986 — 1991
Bachelor of Science (BS), Industrial Engineering
Philippines
Diane Rutherford's Ken Block Consulting Experience August 2012 - Present
Job at Ken Block Consulting
Industry Medical Devices
Experience
Ken Block Consulting August 2012 - Present
Skills
FDA
Education
University of North Texas 2002 — 2008
MS, Materials Science and Engineering
The University of Texas at Arlington 1995 — 1998
BS, Mechanical Engineering
Brookhaven Community College 1992 — 1994
AAS
Ken Block Consulting August 2012 - Present
Skills
FDA
Education
University of North Texas 2002 — 2008
MS, Materials Science and Engineering
The University of Texas at Arlington 1995 — 1998
BS, Mechanical Engineering
Brookhaven Community College 1992 — 1994
AAS
Ronald Gerner's Ken Block Consulting Experience June 2009 - September 2009
Job Independent Quality System Consultant
Industry Medical Devices
Experience
R M Gerner Consulting November 2008 - Present
Philips Healthcare October 2014 - February 2015
Fresenius Medical Care August 2013 - October 2014
Kinetic Concepts March 2013 - August 2013
Philips Healthcare/Validant Consulting June 2011 - March 2013
Abbott Laboratories Medical Optics Division August 2009 - March 2011
Ken Block Consulting June 2009 - September 2009
Abbott Laboratories Diagnostics Division 1996 - 2009
Abbott Laboratories 1986 - 1996
Printronix Inc 1983 - 1985
Skills
Computer System..., CAPA, Process Improvement, Quality Assurance, Quality Auditing, Software Engineering..., Software Validation, Project Management, Design Control, 21 CFR Part 11, GAMP5, Quality Management, Quality System, GAMP, Validation, FDA, SDLC, Testing, Software Documentation, GMP, ISO, Quality Control, Sop, Regulatory Affairs, Change Control, Product Development, R&D, ISO 13485, Auditing, Root Cause Analysis, V&V, Software Quality..., GxP, Medical Devices, Training, Six Sigma, Software Development, Cross-functional Team..., Regulatory Requirements, ERP, Manufacturing, Iso 9000, SOP, ISO 9000
Education
Northern Illinois University 1979 — 1982
BS, Computer Science
R M Gerner Consulting November 2008 - Present
Philips Healthcare October 2014 - February 2015
Fresenius Medical Care August 2013 - October 2014
Kinetic Concepts March 2013 - August 2013
Philips Healthcare/Validant Consulting June 2011 - March 2013
Abbott Laboratories Medical Optics Division August 2009 - March 2011
Ken Block Consulting June 2009 - September 2009
Abbott Laboratories Diagnostics Division 1996 - 2009
Abbott Laboratories 1986 - 1996
Printronix Inc 1983 - 1985
Skills
Computer System..., CAPA, Process Improvement, Quality Assurance, Quality Auditing, Software Engineering..., Software Validation, Project Management, Design Control, 21 CFR Part 11, GAMP5, Quality Management, Quality System, GAMP, Validation, FDA, SDLC, Testing, Software Documentation, GMP, ISO, Quality Control, Sop, Regulatory Affairs, Change Control, Product Development, R&D, ISO 13485, Auditing, Root Cause Analysis, V&V, Software Quality..., GxP, Medical Devices, Training, Six Sigma, Software Development, Cross-functional Team..., Regulatory Requirements, ERP, Manufacturing, Iso 9000, SOP, ISO 9000
Education
Northern Illinois University 1979 — 1982
BS, Computer Science