A Medical Device professional with ten years experience in management and development of Quality and Regulatory programs.  Excellent at identifying and resolving issues using systematic analysis and problem-solving skills.

Titles Held: Director of Quality Systems; Manager Quality Control; Manager QA/RA

• Managed ISO/cGMP compliance and coordinated QA/QC activities of a medical device Quality System
• Hands-on experience with Compliance; Process Improvement; Root Cause Analysis, Risk Analysis
• Process Development; Design Control of the DHF & DMR
• Upgraded and managed processes for: Complaints, Corrective and Preventive Action (CAPA), material review board (MRB), product change control (CO), Design History File & Review and supplier quality programs
• Directly involved with FTA, FMECA, DFM reviews, CE conformance reviews, and the design review; ISO 14971, FMEA and risk management plans