Ray Witherspoon resumes & CV records
Resumes
Searching For New Opportunities: Fda, Iso, Osha, Qsm/R, Hipaa-Hitech/Jcaho -- Corporate Auditor/Compliance Officer
Position:
Principal Healthcare Consultant - Independant Contractor at Memphis Consulting Group, LLC, Consultant at HeartbeatCPR, Principal Consultant at CSpoon & Associates, Board Member at Dunklin Family {Mother}, Family Member at Yarber Family {Father}
Location:
Greater Memphis Area
Industry:
Medical Devices
Work:
Memphis Consulting Group, LLC
- Memphis TN since Jul 2011
Principal Healthcare Consultant - Independant Contractor HeartbeatCPR - Greater Memphis Area since Jun 2011
Consultant CSpoon & Associates - Greater Memphis Area since Apr 2003
Principal Consultant Dunklin Family {Mother} - Bastrop, LA since 1985
Board Member Yarber Family {Father} - Texarkana, AR since Mar 1982
Family Member Priority Sleep Diagnostics - Memphis TN Aug 2011 - Apr 2012
Associate Director Healthcare Services - Independent Contractor Tissue Banks International - The National Eye Bank Center - Memphis, TN Aug 2007 - Apr 2011
QA/Compliance Officer Johnson & Johnson Health Care Systems Inc. - Memphis TN Apr 2007 - Aug 2007
Senior Analyst – Environmental, Health & Safety Thomas & Betts Corporation - Byhalia, MS Aug 2003 - Apr 2007
Safety Specialist Greater Memphis Association for Quality - Memphis, TN Jan 1997 - Dec 2003
Quality Examiner Smith & Nephew Orthopaedics - Memphis, TN Jul 1982 - Jan 2001
Manager – Product Quality Systems [Product Base Systems] Richards Medical (Smith & Nephew) - Memphis, TN Jan 1979 - Jun 1982
Manager - Engineering Graphics
Principal Healthcare Consultant - Independant Contractor HeartbeatCPR - Greater Memphis Area since Jun 2011
Consultant CSpoon & Associates - Greater Memphis Area since Apr 2003
Principal Consultant Dunklin Family {Mother} - Bastrop, LA since 1985
Board Member Yarber Family {Father} - Texarkana, AR since Mar 1982
Family Member Priority Sleep Diagnostics - Memphis TN Aug 2011 - Apr 2012
Associate Director Healthcare Services - Independent Contractor Tissue Banks International - The National Eye Bank Center - Memphis, TN Aug 2007 - Apr 2011
QA/Compliance Officer Johnson & Johnson Health Care Systems Inc. - Memphis TN Apr 2007 - Aug 2007
Senior Analyst – Environmental, Health & Safety Thomas & Betts Corporation - Byhalia, MS Aug 2003 - Apr 2007
Safety Specialist Greater Memphis Association for Quality - Memphis, TN Jan 1997 - Dec 2003
Quality Examiner Smith & Nephew Orthopaedics - Memphis, TN Jul 1982 - Jan 2001
Manager – Product Quality Systems [Product Base Systems] Richards Medical (Smith & Nephew) - Memphis, TN Jan 1979 - Jun 1982
Manager - Engineering Graphics
Education:
Christian Brothers University 1985 - 1988
BS, Management, Economics/Finance Santa Monica College 1974 - 1977
AS, Manufacturing Technology
BS, Management, Economics/Finance Santa Monica College 1974 - 1977
AS, Manufacturing Technology
Skills:
Process Improvement, Quality Systems, Change Management, FDA, Healthcare, Continuous Improvement, Documentation, HIPAA, HITECH, OHSA, Medical Devices, OSHA, Quality System, Software Documentation, Root Cause Analysis, ISO, Quality Management, Manufacturing, Validation, CAPA, Quality Assurance, Cross-functional Team Leadership, Leadership, Auditing, Risk Assessment, Training, Management, Quality Control, GMP, ISO 13485, Sop, 21 CFR Part 11, Biotechnology, Quality Auditing, Design Control, Project Management, CE marking, Regulatory Requirements, Policy, SPC, Product Launch, Iso 9000, Laboratory, ISO 14971, Product Development
Interests:
HIPAA- Administrative Simplification Compliance Act
Languages:
English
Awards:
Corporate Recognition
Unival, Inc/City of Memphis/Thomas and Betts/Greater Memphis Association for Quality/Sherpa Inc/Smith & Nephew
•Clinical Site Reviews, Recognition 2005, Unival, Inc. •Corporate Safety Recognition, 2005, Most Improved Division; Thomas and Betts, Corp. •Certification of Appreciation, Mayor City of Memphis, HR-Quality Award for Excellence Judge •Participated in “Focus on Value” program (process improvements), $3 million/ 25,000 hrs savings - Smith & Nephew •Co-authored the application for “Greater Memphis Association for Quality” Level 3 Award - granted •Commendation Letter (1996), Group Director of Regulatory Affairs, Regulatory Information Technology Task Force - Smith & Nephew •Commendation Letter (1993 and 1995) from Sherpa Inc., “Product Data Management - FDA Regulated Environment” at the International User Conference
Safety & Compliance Mandated Certified Training
Johnson & Johnson Healthcare Systems, Inc.
•Safety; 29 CFR 1910 •IATA/ICAO Dangerous Goods Regulations 49th Edition •HIPAA/Patient Privacy; 45 CFR Parts 160, 162 and 164 •Ethics & Labor Laws; HCCA (Health Care Compliance Association) •Records Management; ISO 13485 – Quality Systems Management •Healthcare Compliance; HCCA (Health Care Compliance Association) •Hazardous Materials Regulations; 40 CFR - Protection of Environment •Adverse Event and Product Quality Complaint Awareness; MedWatch FDA Adverse Event Reporting
OSHA 29 CFR Part 1910 Occupational and Health Standards Certified Training
National Safety Council/Rockhurst University/Clean Harbors Environmental Service
•Safety Certificate, 2006, National Safety Council •OSHA Compliance & Workplace Safety, Certification 2005, Rockhurst University •Certificate of Achievement, 2007, Clean Harbors Environmental Service, Hazardous/Toxic Waste Management •Certified OSHA Compliance and Workplace Safety/Comply w/OSHA Recordkeeping Requirements, Rockhurst University
HIPAA Compliance Training
SHARP (Southern HIPAA Administrative Regional Process) Workgroup
•HIPAA 45 CFR Parts 160, and 164 Certification, 2003, HIPAAsystems – SHARP (Southern HIPAA Administrative Regional Process) Workgroup
Regulatory Affairs/Compliance
Center for Professional Advancement Training
•Validation Medical Device Hardware and Software, FDA •Good Manufacturing Practices for Medical Devices, FDA •Regulatory Requirements for Marketing Medical Devices, FDA
Specialized Training
•GMP Facility Design and Construction, Construction Professional Council of Memphis •Certified Manufacturing Engineering Technologist, Society of Manufacturing Engineering •Certified Quality Examiner Greater Memphis Association for Quality [Malcolm Baldrige Model for Quality] •Certificate of Achievement, 2007/2008, EPA 40 CFR 262 Generators Of Hazardous Waste, EPA 40 CFR 265 Interim Status Standards For Owners And Operators Of Hazardous Waste Treatment, Storage, And Disposal Facilities; Lion Technology, Hazardous/Toxic Waste Management
Unival, Inc/City of Memphis/Thomas and Betts/Greater Memphis Association for Quality/Sherpa Inc/Smith & Nephew
•Clinical Site Reviews, Recognition 2005, Unival, Inc. •Corporate Safety Recognition, 2005, Most Improved Division; Thomas and Betts, Corp. •Certification of Appreciation, Mayor City of Memphis, HR-Quality Award for Excellence Judge •Participated in “Focus on Value” program (process improvements), $3 million/ 25,000 hrs savings - Smith & Nephew •Co-authored the application for “Greater Memphis Association for Quality” Level 3 Award - granted •Commendation Letter (1996), Group Director of Regulatory Affairs, Regulatory Information Technology Task Force - Smith & Nephew •Commendation Letter (1993 and 1995) from Sherpa Inc., “Product Data Management - FDA Regulated Environment” at the International User Conference
Safety & Compliance Mandated Certified Training
Johnson & Johnson Healthcare Systems, Inc.
•Safety; 29 CFR 1910 •IATA/ICAO Dangerous Goods Regulations 49th Edition •HIPAA/Patient Privacy; 45 CFR Parts 160, 162 and 164 •Ethics & Labor Laws; HCCA (Health Care Compliance Association) •Records Management; ISO 13485 – Quality Systems Management •Healthcare Compliance; HCCA (Health Care Compliance Association) •Hazardous Materials Regulations; 40 CFR - Protection of Environment •Adverse Event and Product Quality Complaint Awareness; MedWatch FDA Adverse Event Reporting
OSHA 29 CFR Part 1910 Occupational and Health Standards Certified Training
National Safety Council/Rockhurst University/Clean Harbors Environmental Service
•Safety Certificate, 2006, National Safety Council •OSHA Compliance & Workplace Safety, Certification 2005, Rockhurst University •Certificate of Achievement, 2007, Clean Harbors Environmental Service, Hazardous/Toxic Waste Management •Certified OSHA Compliance and Workplace Safety/Comply w/OSHA Recordkeeping Requirements, Rockhurst University
HIPAA Compliance Training
SHARP (Southern HIPAA Administrative Regional Process) Workgroup
•HIPAA 45 CFR Parts 160, and 164 Certification, 2003, HIPAAsystems – SHARP (Southern HIPAA Administrative Regional Process) Workgroup
Regulatory Affairs/Compliance
Center for Professional Advancement Training
•Validation Medical Device Hardware and Software, FDA •Good Manufacturing Practices for Medical Devices, FDA •Regulatory Requirements for Marketing Medical Devices, FDA
Specialized Training
•GMP Facility Design and Construction, Construction Professional Council of Memphis •Certified Manufacturing Engineering Technologist, Society of Manufacturing Engineering •Certified Quality Examiner Greater Memphis Association for Quality [Malcolm Baldrige Model for Quality] •Certificate of Achievement, 2007/2008, EPA 40 CFR 262 Generators Of Hazardous Waste, EPA 40 CFR 265 Interim Status Standards For Owners And Operators Of Hazardous Waste Treatment, Storage, And Disposal Facilities; Lion Technology, Hazardous/Toxic Waste Management
Certifications:
Certified Manufacturing Engineering Technologist, Society of Manufacturing Engineering
Hazardous/Toxic Waste Management, Lion Technology, Inc.
Scholastic Achievement - Drafting Engineering Technology, Los Angeles Southwest College
Quality Examiner, The Great Memphis Association for Quality
Manufacturing Engineering Technologist, Santa Monica College
Hazardous/Toxic Waste Management, Lion Technology, Inc.
Scholastic Achievement - Drafting Engineering Technology, Los Angeles Southwest College
Quality Examiner, The Great Memphis Association for Quality
Manufacturing Engineering Technologist, Santa Monica College
Vp At Spoon & Associates
Position:
VP at spoon & associates
Location:
Greater Memphis Area
Industry:
Machinery
Work:
spoon & associates
VP
VP
Manager Regulatory Affairs And Quality Systems
Location:
Jackson, TN
Industry:
Pharmaceuticals
Work:
Mckesson
Manager Regulatory Affairs and Quality Systems Memphis Consulting Group Jul 2011 - Mar 2015
Compliance Assessment and Principal Healthcare Consultant - Independent Contractor Baxter International Inc. Oct 2014 - Dec 2014
Senior Lead Capa Auditor and Investigator [Short-Term; Year-End Project Depuy Synthes Johnson & Johnson Jun 2013 - Mar 2014
Quality and Compliance Auditor - Facility and Equipment Control - Independent Contractor Priority Sleep Diagnostics Aug 2011 - Apr 2012
Associate Director Healthcare Services - Independent Contractor Tissue Banks International Aug 2007 - Apr 2011
Quality Assurance and Compliance Officer Johnson & Johnson Apr 2007 - Aug 2007
Senior Analyst à   Environmental, Health and Safety Thomas & Betts Aug 2003 - Apr 2007
Safety Specialist Greater Memphis Association For Quality Jan 1997 - Dec 2003
Quality Auditor Smith & Nephew Jul 1982 - Jan 2001
Manager à   Quality Systems Smith & Nephew Jan 1979 - Jun 1982
Manager - Engineering Graphics
Manager Regulatory Affairs and Quality Systems Memphis Consulting Group Jul 2011 - Mar 2015
Compliance Assessment and Principal Healthcare Consultant - Independent Contractor Baxter International Inc. Oct 2014 - Dec 2014
Senior Lead Capa Auditor and Investigator [Short-Term; Year-End Project Depuy Synthes Johnson & Johnson Jun 2013 - Mar 2014
Quality and Compliance Auditor - Facility and Equipment Control - Independent Contractor Priority Sleep Diagnostics Aug 2011 - Apr 2012
Associate Director Healthcare Services - Independent Contractor Tissue Banks International Aug 2007 - Apr 2011
Quality Assurance and Compliance Officer Johnson & Johnson Apr 2007 - Aug 2007
Senior Analyst à   Environmental, Health and Safety Thomas & Betts Aug 2003 - Apr 2007
Safety Specialist Greater Memphis Association For Quality Jan 1997 - Dec 2003
Quality Auditor Smith & Nephew Jul 1982 - Jan 2001
Manager à   Quality Systems Smith & Nephew Jan 1979 - Jun 1982
Manager - Engineering Graphics
Education:
Johnson & Johnson Law School 2007
Christian Brothers University 1985 - 1988
Bachelors, Bachelor of Science, Economics, Management, Finance Santa Monica College 1974 - 1977
Los Angeles Southwest College
Rockhurst University
Santa Monica College
Associates
Christian Brothers University 1985 - 1988
Bachelors, Bachelor of Science, Economics, Management, Finance Santa Monica College 1974 - 1977
Los Angeles Southwest College
Rockhurst University
Santa Monica College
Associates
Skills:
Fda, Quality System, Quality Assurance, Medical Devices, Process Improvement, Capa, Leadership, Validation, Iso 13485, Management, Quality Auditing, Quality Management, Manufacturing, Training, Healthcare, Software Documentation, Root Cause Analysis, Iso, Continuous Improvement, Project Management, Change Management, Regulatory Affairs, Cross Functional Team Leadership, 21 Cfr Part 11, Quality Control, Sop, Commercialization, U.s. Food and Drug Administration, Corrective and Preventive Action, Product Development, Business Process Improvement, Gmp, Biotechnology, Hipaa, Change Control, Auditing, Computer System Validation, Product Launch, Risk Assessment, Design Control, Regulatory Requirements, Standard Operating Procedure, Osha, Iso 14971, Design of Experiments, V&V, Iso Standards
Interests:
Social Services
Economic Empowerment
Civil Rights and Social Action
Poverty Alleviation
Science and Technology
Health
Economic Empowerment
Civil Rights and Social Action
Poverty Alleviation
Science and Technology
Health
Languages:
English
Certifications:
Certified Manufacturing Engineering Technologist
Hazardous/Toxic Waste Management
Scholastic Achievement - Drafting Engineering Technology
Quality Examiner
Manufacturing Engineering Technologist
License 2019941
License 300-7662
License Lasc.edu/
Society of Manufacturing Engineering, License 2019941
Lion Technology, Inc., License 300-7662
Los Angeles Southwest College, License Lasc.edu/
The Great Memphis Association For Quality
Santa Monica College, License 2019941
Hazardous/Toxic Waste Management
Scholastic Achievement - Drafting Engineering Technology
Quality Examiner
Manufacturing Engineering Technologist
License 2019941
License 300-7662
License Lasc.edu/
Society of Manufacturing Engineering, License 2019941
Lion Technology, Inc., License 300-7662
Los Angeles Southwest College, License Lasc.edu/
The Great Memphis Association For Quality
Santa Monica College, License 2019941
Compliance Officer
Location:
Memphis, TN
Industry:
Biotechnology
Work:
National Eye Bank Center
Compliance Officer
Compliance Officer
Vice President
Location:
Memphis, TN
Work:
Spoon & Associates
Vice President
Vice President
Ray Witherspoon - Memphis, TN
Work:
Memphis Consulting Group, LLC Oct 2011 to 2000
Principal Healthcare Consultant CSPOON AND ASSOCIATES [Self-Employed] 2002 to 2000
Principal Consultant Baxter Healthcare Corp - Cleveland, MS Oct 2014 to Dec 2014
CAPA Investigator/Auditor DePuy Synthes - Johnson & Johnson - West Chester, PA Jun 2013 to Feb 2014
Quality/Compliance Auditor CareFusion, Inc [Saint Francis Hospital] - Bartlett, TN Apr 2013 to May 2013
Quality Engineer Tissue Bank International, The National Eye Bank Center - Memphis, TN Aug 2007 to Apr 2011
Quality Systems / Compliance Officer Johnson & Johson Health Care Systems Inc - Memphis, TN Apr 2007 to Aug 2007
Senior Analyst Environmental and Safety Thomas & Betts Corporation - Byhalia, MS Aug 2003 to Apr 2007
Safety Specialist Smith & Nephew Orthopaedic - Memphis, TN Jan 1982 to Jan 2001
Manager - Quality Systems
Principal Healthcare Consultant CSPOON AND ASSOCIATES [Self-Employed] 2002 to 2000
Principal Consultant Baxter Healthcare Corp - Cleveland, MS Oct 2014 to Dec 2014
CAPA Investigator/Auditor DePuy Synthes - Johnson & Johnson - West Chester, PA Jun 2013 to Feb 2014
Quality/Compliance Auditor CareFusion, Inc [Saint Francis Hospital] - Bartlett, TN Apr 2013 to May 2013
Quality Engineer Tissue Bank International, The National Eye Bank Center - Memphis, TN Aug 2007 to Apr 2011
Quality Systems / Compliance Officer Johnson & Johson Health Care Systems Inc - Memphis, TN Apr 2007 to Aug 2007
Senior Analyst Environmental and Safety Thomas & Betts Corporation - Byhalia, MS Aug 2003 to Apr 2007
Safety Specialist Smith & Nephew Orthopaedic - Memphis, TN Jan 1982 to Jan 2001
Manager - Quality Systems
Education:
Santa Monica College - Santa Monica, CA Jan 1976 to Jan 1997
Diploma in Manufacturing Engineering Technology Christian Brothers University - Memphis, TN Jan 1985 to Jan 1988
B.S. in Management and Economics/Finance Santa Monica College - Santa Monica, CA Jan 1976 to Jan 1977
AA in Manufacturing Engineering Technology Los Angeles Southwest College - Los Angeles, CA Jan 1972 to Jan 1974
Certification in Drafting Engineering Graphics
Diploma in Manufacturing Engineering Technology Christian Brothers University - Memphis, TN Jan 1985 to Jan 1988
B.S. in Management and Economics/Finance Santa Monica College - Santa Monica, CA Jan 1976 to Jan 1977
AA in Manufacturing Engineering Technology Los Angeles Southwest College - Los Angeles, CA Jan 1972 to Jan 1974
Certification in Drafting Engineering Graphics
Skills:
Data Base Mgmt Systems, Engrg Graphics, FDA, EBAA, OSHA, SOPs, Document Control