SUMMARY Accomplished and result-driven Quality and Regulatory Affairs professional with 15 years of experience in the Medical device and Drug industry, along with over 17 years of leadership, project management and process improvement (Six Sigma or lean manufacturing). ACCOMPLISHMENTS * Developed, implemented and managed quality systems in GMP and GCP settings based on FDA, ISO, MDD, CMDR, ICH, and IEC regulations and guidance documents. Systems included design and document controls verification and validation complaint handling CAPA processing training internal audits supplier controls environmental monitoring incoming/in-process inspection, final acceptance and stability testing * Developed processes for supplier management and completed supplier approvals and audits of contract manufacturers, test labs, and key suppliers. Completed on-site inspections of suppliers manufacturing and quality systems, resulting in process improvements and improved relationships. * Provided leadership and direction for the Quality Assurance department, including Document Control, Audit, Quality Control and CAPA Management systems utilizing risk management tools such as FMEA, fish bone and requirements from ISO 14971. Supervised, both exempt and non-exempt personnel, this included hiring, performance appraisals, salary reviews, coaching/mentoring, and disciplinary issues.

Highlights:

• Training
• Cardiovascular
• CT
• Documentation
• Imaging
• Magnetic Resonance Imaging (MRI)
• Management
• Medical