Dynamic, results oriented Medical Device Manufacturing Operations Executive who has demonstrated the ability to lead diverse cross-functional teams to new levels of success in medical device manufacturing. Strong analytical, technical and business qualifications with an impressive track record of more than 16 years of hands-on experience in strategic planning, business unit development, project and product management, and system engineering strategies. Proven ability to successfully analyze an organization's critical business requirements, identify deficiencies and potential opportunities, and develop innovative and cost-effective solutions for enhancing competitiveness, increasing revenues, improving customer service, while maintaining FDA, ISO, and QSR regulatory compliance.

Highlights:

• FDA
• ISO 13485
• 21 CFR 820
• cGMP
• Medical Device
• Manufacturing
• Operations
• Production
• Development Activities
• Documentation
• Medical
• Medical Devices
• Sourcing
• Enterprise Requirements Planning
• NCR
• SAP
• Development Activities
• Documentation
• Medical
• Medical Devices
• Sourcing
• Enterprise Requirements Planning
• NCR
• SAP