Business Forms and Information

With over three decades of extensive experience, my expertise lies   in developing and supporting business objectives, projects, services, and   products, focusing on customer requirements and critical to quality (CTQ) parameters.   My teams have designed processes and products, including electrosurgical   generators, powered surgical staplers, and flat-screen display assemblies   that meet stringent regulations, such as 21 CFR 820 and 14 CFR 21. My   proficiency extends to the medical products sector. I managed the Systems   Team within the Technology and Development Group for Applied Medical   resources from 2017 to 2022, focusing on risk management and regulatory   compliance for medical devices. I have collaborated closely with Notified   Bodies for UL Certification and CE Marking, ensuring successful product   registration and compliance in US, European, and Asian markets. 

I have implemented and maintained quality management systems in   compliance with ISO 13485, AS9100, and ISO 9000, ensuring top-tier device   production and quality control standards. By leveraging my advanced expertise   in process improvement, organizational leadership, and certifications such as   ASQ's CSSBB and CMQ/OE, as well as APICS-BOK, CPIM, and CSCP, I have optimized   operations, achieved business objectives, and enhanced supply chain   management and inventory control within the medical device industry. I have   applied ISO 14971 for risk management in medical device development, helping   to ensure the identification, analyzing, and controlling potential hazards   throughout the product lifecycle. My knowledge spans optics, electronics,   mechanical, and software engineering, as well as business and quality   assurance processes. I held P&L responsibility from 2003 to 2012, and as   the inventor of five patents, I have consistently contributed to innovation   in various industries.

Recently relocated to Venice, FL. Open to 1099 and W2 opportunities, local Florida and remote   opportunities.