Urey Kang Email & Phone Number

New York, United States

Greater New York City Area

Head a team of domestic and international quality inspectors to identify, quarantine, and resolve defective materials.

Manage enterprise-wise quarantine inventory from defect identification and segregation to disposition and stock release across multiple distribution centers.

Milford, CT

• Led efforts in maintaining licenses, registrations, and listings for the company and its products by serving as the Management Rep between the company and the FDA / European Union / Health Canada regulatory bodies
• Communicated quarterly updates to executive management on Quality Objectives such as customer satisfaction, failure trends, internal/external audit results and regulatory updates
• Established and conducted a monthly internal audit program of the quality system processes to ensure compliance with regulatory standards and company policies
• Performed on-boarding and continuous trainings of QMS processes for all employees and maintained training records
• Spearheaded and successfully completed an FDA Premarket Notification – Traditional 510k for a Class II SaMD by coordinating efforts between regulatory, engineering, marketing, and manufacturing departments
• Conducted phase audits throughout software development lifecycle to ensure compliance with all requirements of IEC 62304 Medical device software - Software life cycle processes

• Conducted risk analyses including preliminary hazard analysis (PHA), FMEA, risk minimization implementation, and post-market surveillance in accordance with ISO 14971
• Supervised each Nonconforming Material Reporting (NCMR) and CAPA from issuance through closure
• Advanced products development through escalating Post Market complaints to product management and engineering departments
• Performed Quality Control testing on software medical device with feedback loop on test plan improvements

• Streamlined the software validation process by formulating a traceability matrix
• Complied product literature for Medical Device Record and Design History File maintenance
• Drafted medical device user manual updates based on new product features and developments

B.S, Engineering Science; Biomedical Engineering Design

Activities and Societies: Vietnamese Students Club, Tufts Taekwondo Team

Psychology

International Summer Program