Yao-Hsuan T.
Ra Qa Specialist @Asensus Surgical
Signup · Get unlimited contacts
WORK HISTORY
Ra Qa Specialist @Asensus Surgical
Durham, NC, US
Regulatory Affairs: Knowledgeable and experienced in TFDA license and QSD registration management.• FDA Compliance: Experienced in supporting FDA 510k registration processes.• Post Market Feedback Regulatory Evaluation: Collected customer feedback and conducted initial and follow-up regulatory evaluations in the US, Japan, and Taiwan.• Quality Management: Competent in CAPA and complaint handling.• Design Control: Skilled in maintaining Design History Records.• Non-Conformance Management: Proficient in supporting the management of NCMR.• Supplier Audit: Conducted comprehensive international supplier audits, analyzing SOPs and work instructions, and facilitating virtual meetings. Proficiently documented findings in detailed audit reports.
EDUCATION
Duke University Pratt School of Engineering
Master of Engineering - MEng, Biomedical/Medical Engineering
National Chengchi University
Master of Science - MS, Innovation & Intellectual Property Management
National Yang Ming University
Bachelor's degree, Biomedical Engineering
ABOUT YAO-HSUAN T.
Regulatory Affairs / Quality Engineering | Medical Device Design | Duke MEng Biomedical Engineering
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.