Improver

Ray Witherspoon

Manager Regulatory Affairs & Quality

Memphis, Tennessee

Regulatory Affairs & Quality Systems Manager in the Pharmaceutical & Medical Industry:

•Products; trauma / spine devices, total joint replacement, infusion systems, bone simulator, cardiovascular /endovascular devices, reagent, diagnostic test kit, OTC, surgical instrumentation, ocular/pericardium tissue.

•Assessed suppliers, nonconforming, and damage product reviews (SOPs, raw material, tooling semi/finished goods, clinical medical supplies). HazMat disposal.

•Authored /edited and executed computer / software (bar coding / SharePoint / PLM IQ/OQ/PQ quality documentation and test scripts; 21 CFR Part 11.

•Authored and executed master validation projects for medical equipment qualification IQ/OQ/PQ.

•Managed staff of 12 technical personnel (supervisor, product analysts, documentation coordinators, data entry clerks and specification developers) DHR / DMR.

•Performed/co-hosted internal / external audits (60 approx.) FDA 483, FDA CFR 21 Part 820/1271, ISO 9001/13485, OSHA 29 CFR Part 1910, EBAA Medical Standards, internal processes.

•Project Leader- Cleanroom/Electronic Environmental Monitoring System Commissioning/Validation implementation.

•Managed Design, Document and Change Control Processes and Risk Management per 21 CFR Part 820.

•Event/CAPA/Compliant Investigations (approx. 300 plus) investigation, reporting, trends / cause analysis; 21 CFR Part 803.

•Authored /edited, executed, managed and trained SOPs [5] for PLM / manufacturing / inventory control systems (SAP, COPICS, BPCS, Matrix) user utilization, global change control [approx. 1100 annually] , material / process specifications / requirements [200 – 300 specifications].


I am interested in pursuing compliance / quality /auditor position or an entrepreneurial opportunity focusing on safety, quality, and/or compliance in the medical device and related industries / sectors.

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Experience:

• Auditor - Principal Consultant (CSpoon & Associates [Self-Employed])
• Compliance Assessment / Principal Healthcare Consultant - Independent Contractor (Memphis Consulting Group, LLC)
• Quality / Compliance Auditor - Facility & Equipment Control - Independent Contractor (DePuy Synthes Johnson & Johnson)
• Senior Lead CAPA Auditor/Investigator [Short-Term; Year-End Project] (Baxter International Inc.)
• Manager Regulatory Affairs and Quality (McKesson Corporation)

Skills:

• Regulatory Affairs
• Training
• Design of Experiments
• Commercialization
• Quality Control
• ISO 14971
• Product Development
• V&V
• Design Control
• Change Control
• Regulatory Requirements
• Biotechnology
• Standard Operating Procedure (SOP)
• Quality Auditing
• Project Management
• GMP
• Product Launch
• ISO 13485
• Computer System Validation
• Management
• 21 CFR Part 11
• Cross-functional Team Leadership
• U.S. Title 21 CFR Part 11 Regulation
• Leadership
• Root Cause Analysis
• CAPA
• Sop
• Quality Assurance
• OSHA
• Manufacturing
• Validation
• HIPAA
• Quality System
• Healthcare
• Continuous Improvement
• Auditing
• ISO
• Risk Assessment
• FDA
• Quality Management
• Medical Devices
• Change Management
• Software Documentation
• Process Improvement
• Business Process Improvement
• ISO Standards
• Corrective and Preventive Action (CAPA)
• U.S. Food and Drug Administration (FDA)
• SOP