Certified Quality Auditor with twenty-five years of experience.  Extensive broad-based knowledge in Quality Assurance with a successful record of introducing and implementing quality systems across multiple locations.

Titles Held: Director of Quality Assurance; Manager of Design Assurance; Manager of Quality Assurance; Senior Project Engineer; Quality Control Engineer

• Vast exposure to Medical Device Regulations including cGMPs and ISO 13485:2003
• Experienced engineer with a passion for new product development; well-versed in submission work as well
• Strong in Design Controls, CAPA’s and Quality Systems implementation
• In-depth knowledge of Class II, disposables, surgical instruments and catheters
• Quality Assurance experience in Europe, Asia, Ireland, China and Germany