Six Sigma Green belt professional experienced in Quality, Compliance and Regulatory for the Medical Device, Biologics, Pharmaceutical and Combination Products industries.  Expertise in preparation and evaluation of Regulatory, Compliance and New Product Development Systems.

Titles Held: World-wide Manager Strategic Quality Combination Products; Quality Manager; Senior Quality Systems Consultant; Director of Regulatory/Quality Systems/Clinical Affairs; Regulatory Coordinator

• Strong Regulatory background in regards to warning letters, recalls, protocol writing, 510(k), PMAs, IDEs, PLAs/ELAs
• Skilled in Quality systems development and deployment; New product development process from R&D to Launch
• International experience working in EU, Canada, Puerto Rico and Mexico; CE Marking and device certification
• ASQ Auditor proficient in Supplier/Contract manufacturer audits
• Experienced Trainer in the areas of GMPs, cGMPs, GLPs, GCPs, QSRs, ISO 9000, 13485, Design Controls, Internal Auditor and Combination Products