Billy Wiggins Email & Phone Number

Post-market surveillance and CAPA facilitation expert with over 20 years of quality assurance and regulatory compliance experience. Extensive experience in developing quality management systems, auditing, and trending processes. Led cross-functional teams for regulatory compliance and remediation on multiple projects involving budgets of $500K up to $20MM. Broad experience with the US FDA and international governmental regulatory agencies in Europe, South America, and Asia for auditing, regulatory activities, and quality compliance.

• Managing Director

  Qualitis Consulting, Llc

  Sep 2012 - Present - Daytona Beach, Florida, United States

  Providing Quality and Regulatory compliance services to the Medical Device and Biotechnology industry Worldwide.September 2012 – June 2023Sr. Regulatory and Quality Compliance Consultant- Post-Market Surveillance, Complaint and Adverse Event Management, and CAPA Facilitation. Led teams of 5 to 100 consultant contractors on FDA Warning Letter and Consent Decree resolution projects for multiple US and European clients involving Class I, II, and III medical devices. Worked as a CAPA facilitator at a Pharma CRO for two years, supporting interdepartmental and cross-functional resources in all aspects of CAPA activity, including scheduling CAPA team meetings and ensuring CAPA deliverables according to established SOP timelines for resolving assigned CAPAs. Monitored Verification of Effectiveness (VoE) per established procedures and supported CAPA Owners during audits and CAPA Review Board meetings. Worked as adverse event research lead on a combination drug/devise project for a COVID-19 vaccine. Manager, Post-Market Surveillance Department Medtronic Xomed- Jacksonville, FLApr 2001-Jan 2012Managed five FTEs and 12 Contractors for the evaluation, investigation, and response to more than 9,600 product quality complaints and technical inquiries per year in a call center setting.Directed the recruiting, training, employee performance, and development of the Customer Loyalty Supervisor, MDR Specialists, and Customer Loyalty Specialist. Led the Regulatory reporting process for adverse events and field corrective actions for Class II devices. Provided Corporate Quality and Regulatory management updates regarding the Global Complaint Process, Complaint Trending, CAPA resolution, and system performance metrics. Provided customer experience feedback to R&D for new product development and Health Hazard Analysis for Risk Management Reports. Developed and managed quality plans, gap analysis, and corrective actions for corporate and regulatory agency audits.