We are an accomplished successful and compliant Quality Assurance professionals for a broad range of functions within a global environment. We have led the development, maintenance and relentless improvement of a balanced quality/regulatory system, managed efficiency, and compliance for class I through class III medical devices.
Innovator of the development and implementation of a supplier certification program. Creator of inspection procedures and test methods to improve efficiency. Successfully led and managed implementation and transitions of quality management systems to achieve ISO 13485 certification. Strategically planned, harmonized, and streamline quality management systems into a flexible and compliant system which improved time-to-market results on a global scale.