I have extensive experience in development and implementation of quality systems in large, international companies requiring broad knowledge of global requirements. I'm a customer-focused project leader with demonstrated communication skills, enabling strong relationship building and a proven track record for leading change initiatives motivating direct and indirect, cross-functional teams, driving pragmatic continuous improvement objectives.Key Strengths: Expert knowledge of ISO 9001, 13485, 21CFR 210, 211, QSR and MDD Requirements Experience in medical device regulated industry Establishment of audit programs, ensuring audit readiness and compliance Managing interactions with 3rd party auditors (FDA, ISO, Customer) Strategic thinking, enabling analysis and balance of business risk Team leadership, coaching, and mentoring in matrixed environment Continuous improvement practices Process metric development Customer relationship managementPlease contact me at denniswitker@optonline.net