Experienced Project Manager, R&D, Post-Market Sustaining, and Quality Engineer who has worked in a very intensely exacting medical device environment.I am a results-focused, self-motivated, and detail-oriented professional with over 15 years of experience in quality, project management, product development/sustaining engineering, and working cross-functionally with regulatory, design quality, supplier quality, materials management, manufacturing, and others.Experienced in Root Cause Analysis & Problem-Solving Techniques. Quality is my first focus and cannot be compromised.Led, contributed and managed multiple teams simultaneously to ensure project on-time completion.Experienced in navigating a quality management system through CAPA and NCR investigation, root cause analysis, ECR/ECO process, and preventative/corrective action implementation.Navigated successful design transfer of multiple design and production and process projects, as project technical lead.Played a critical role in enterprise-level remediation projects driven by FDA 483 observations, warning letters, and consent decree including: production and process controls, CAPA and NCR remediation, design controls, and change control.