Chi-Yang Tseng
New Taipei City
Summary
Expert of product safety evaluation and testing. Knowledge of laboratory quality management. Familiar with certification schemes such as CB, OSHA, CE.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Assistant Manager
SGS Taiwan
New Taipei City
08.2017 - Current
- Being technical support on technical issue in test, construction and report.
- Provided technical consultation for marketing support.
- Facilitated cross-departmental communication to achieve comprehensive solutions.
- Developed standard operating procedures (SOP) for implementing new test capacity.
- Evaluated medical devices including X-Ray, Ultrasound, ECG, EEG, SPO2, Sphygmomanometer, Air pump, Endoscope, HF surgical knife based on IEC60601 series and relevant standards.
- Evaluated measurement, control, and laboratory use device including Multi-meter, Power meter, Programmable logic controller, In vitro diagnosis device, Sterilizer, Centrifuge based on IEC61010 series and relevant standards.
- Knowledge of relevant IEC/ISO standards such as ISO14971, IEC62366, IEC62304, IEC62368, IEC62133, ISO13485, ISO17025.
Engineer
UL Taiwan
Taipei
09.2014 - 07.2017
- Enhanced expertise in safety engineering by specializing in medical, laboratory, and industry control devices (e.g. IEC60601, IEC61010).
- Managed multiple projects involving product safety evaluation, including testing and report writing.
- Implemented project management skill in daily work.
Education
Master of Science - Biomedical Engineering
National Yang-Ming University
Taipei08-2014
Skills
- Product and service knowledge
- Consulting
- Staff Development
- Project management abilities
- Safety evaluation
- Software verification
- Risk management
- Usability engineering
Certification
- IECEE/NRTL authorized reviewer and certificate signator.
- TFDA medical device safety guidelines review committee.
Timeline
Assistant Manager
SGS Taiwan
08.2017 - Current
Engineer
UL Taiwan
09.2014 - 07.2017
Master of Science - Biomedical Engineering
National Yang-Ming University
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