Ray Witherspoon Email & Phone Number

Memphis, TN, US

Jackson, Tennessee, US

FDA-CFRs, ISO, OSHA, EPA consultation and waste reduction strategies

Irving, Texas, US

Master Control LeadQMS Program ManagementCustomer Complaint ReviewWholesale Drug & 3PL Licenses Distribution Agreement ReviewsQuality Agreement Review and ApprovalSuspect and Illegitimate Product Investigation Quality Assurance Drug Quarantine Release Activities SOPs Remediation [cold chain and logistic operations]Lead CAPA investigation; complaints.

Irving, Texas, US

• Develop client retention strategies.
• Develop HIPAA/HITECH Gap Analysis Tool; ref 45 CFR Parts 160, 162 and 164.
• Develop OSHA Gap Analysis Tool; ref OSHA 29 CFR Part 1910 Occupational and Health Standards.

Deerfield, Illinois, US

CAPA Remediation/CAPA Auditor

• Facilitated the development of facility & equipment control audit protocols for legacy systems review.
• Implemented CAPA Global Legacy Review affecting six United States and twelve EU manufacturing sites.
• Implemented audit in accordance to DePuy Synthes Quality Systems Policies, ISO 13485, 21 CFR Part 820

• CareFusion, Inc (04/2013)
• Achieved operational qualification [OQ], labeling, fluid flow rate testing and visual inspection for Alaris IV Infusion System (450 units). ISO 13485 – Quality Systems Management Unival, Inc. (2004 – 2007)
• Performed 25 plus clinical sites audits per sub-parts of TJC (JCAHO), HIPAA 45 CFR Parts 160 and 164, and OSHA 29 CFR Part 1910.Genesis Marketing, LLC (2002 – 2003)
• Developed HIPAA Gap Analysis Tool per 45 CFR Parts 160, 162 and 164.

Business Development

Baltimore, Maryland, US

• Managed facility equipment operational requirements.
• Implemented donor medical record audit criteria and sampling plan per MIL Standard 105D.
• Reviewed suppliers’ quality requirements for cleaning, disinfection and sterilization supplies.
• Performed safety, quality, compliance training, and quality metric reporting; ref ISO 13485 and OSHA 29 CFR Part 1910.
• Created irradiated ocular tissue technical files; ref MDD 93/42/EEC for State of Israel Ministry of Health & South Korea Ministry of Health and Welfare.
• Authored and maintained tissue banking SOPs, CAPA, MedWatch FDA Adverse Event Reporting/21 CFR Part 803 Medical Device Reporting/FDA 21 CFR Part 820/ISO 13485.

New Brunswick, NJ, US

• Managed HazMat waste disposal process per 40 CFR - Protection of Environment.
• Utilized root cause analysis for incident investigations; ref 21 CFR Part 820 and FDA Guidelines for CAPA investigations.
• Established and chaired Safety, Emergency Management, Medical/First Aid, and Safety committees; ref 29 CFR 1910.

• Trained employees on safety regulation.
• Achieved 1,000,000 hours worked w/o lost time incidents.
• Resolved investigation incidents utilizing FDA CAPA guidelines.
• Achieved incident severity rate (1.3%) below industry standard of 7%.
• Developed PPE inventory, assignment, and inspection tracking system.
• Maintained incident report statistics and safety data monthly scorecards.

The Greater Memphis Association for Quality is a nonprofit organization that promotes quality systems and performance/process excellence utilizing the Malcolm Baldrige National Quality Program Criteria for Performance Excellence. As a Quality Examiner, Quality Examiner examines/auditor healthcare organizations processes and documentation to determine.

Watford, Hertfordshire, GB

• Executed ANSI GDT y14.5 into SOPs.
• Executed task requirements to address CAPA.
• Executed requirements/applied 510K, 21 CFR Part 11 and 820, ISO 9001 and 13485 (guidance document).
• Participated/influenced FDA and ISO QMS audits outcomes achieving zero [0] deficiencies.
• Initiated “Medical Device Quality Procedure” process improvement initiative – est. saving $245,000.
• Performed validation (21 CFR Part 11 - IQ, OQ, PQ) for PLM system (automate device master records).

Bs, Management, Economics/Finance

As, Manufacturing Technology