Dawn Nguyen
About Dawn Nguyen
Dawn Nguyen serves as the Director of Quality at Ondine Biomedical Inc., where she has worked since 2020. With over three decades of experience in the medical device industry, she specializes in quality and compliance, and has held various roles in notable companies such as Philips and Physio-Control.
Current Role at Ondine Biomedical
Dawn Nguyen serves as the Director of Quality at Ondine Biomedical Inc., a position she has held since 2020. Based in Bothell, Washington, she has been instrumental in overseeing quality assurance processes and ensuring compliance with industry standards. Her role involves managing quality systems and leading initiatives to enhance product quality and safety. Prior to her current position, she worked as a Quality Engineer at Ondine Biomedical for three months in 2020.
Professional Experience in Medical Device Industry
Dawn Nguyen has over three decades of experience in the medical device industry, with a strong focus on quality and compliance. She has held various roles at Philips, including Field Quality Engineer, Quality & Regulatory Audit Manager, and Regulatory Affairs Specialist II. Her experience also includes positions at Physio-Control, Inc. as Engineering Project Coordinator II and Regulatory Compliance Specialist. This extensive background has equipped her with skills in complaint handling, MDR submissions, and internal auditing.
Educational Background and Certifications
Dawn Nguyen has a solid educational foundation in biomedical regulatory affairs and engineering. She earned a Bachelor of Science in Business Management from the University of Phoenix and an Associate of Applied Science in Electrical, Electronic and Communications Engineering Technology from ITT Technical Institute-Seattle. Additionally, she obtained a Pharmaceutical & Biomedical Regulatory Affairs Certificate from The University of Georgia. Her commitment to continuous learning is evident in her pursuit of knowledge in various fields related to her profession.
Entrepreneurial Ventures
In addition to her roles in the medical device industry, Dawn Nguyen is the owner of Mother Rubber Art Stamps, a business she has managed since 2003 in Issaquah, Washington. This entrepreneurial venture showcases her diverse skill set and ability to manage operations outside the corporate environment. Her experience in administrative support and staff training contributes to her success in running this business.
Skills and Areas of Expertise
Dawn Nguyen possesses a range of skills that enhance her effectiveness in quality management and regulatory compliance. She has proven experience in administrative support, staff training, research, and analysis. Her expertise extends to process improvement, communication, and problem-solving within high-tech manufacturing environments. Additionally, she is knowledgeable in complaint investigations, CAPA management, and audit program management, making her a valuable asset in the medical device sector.