Senior Director, Quality Assurance and Compliance
Pam McNulty is a senior level management and quality professional with expertise in leading quality, engineering, and project/product development teams. Pam’s expertise stems from more than 25 years of experience in the medical device and microelectronics industries. As Senior Director of Quality and Compliance at Yukon Medical, she oversees the activities to maintain and enhance Quality Management System compliance with 21CFR Part 820, ISO 13485, and multiple ever-changing international regulations for vial access and IV administration medical devices. The maintenance and enhancement of the system is critical in that it provides the framework for excellent product quality and exceeding customer expectations.
Pam has led various cross functional teams to obtain several device 510(k) clearances in the U.S., licensing in Canada, and CE Mark in the European Union, facilitating product sales in all these locations. Work is currently underway to register one of the company’s devices in 21 countries.
Previously, Pam facilitated the development of a successful and compliant quality system for a novel implantable radiation dosimeter company in addition to validation of their document control and training systems. She also oversaw the product sterilization program and worked with company management to implement a Change Review Board to facilitate the product change process. And as Intersil Durham’s Management Representative and Development Product and Test Manager, she led and championed several new product development teams, which brought new products to market resulting in $2.1M revenue over five quarters.
Prior to her position at the Intersil design facility, Pam also held various quality and engineering management positions at the company’s microelectronics manufacturing facility in Findlay, Ohio.
Pam earned her Bachelor of Science degree in Ceramic Engineering from Alfred University in New York and completed the BioWorks program at Wake Tech. She is an ASQ certified Manager of Quality and Organizational Excellence and holds a RAC (Regulatory Affairs Certificate) and a Six Sigma Green Belt.