beBee background
Professionals
>
Nottingham
CHUN-YI CHEN

CHUN-YI CHEN

Medical device regulation Affair Specialist

Engineering / Architecture

Nottingham, Nottingham

Social

About CHUN-YI CHEN:

MSc Bioengineering student at University of Nottingham with experience working in the medical device industry, with an emphasis on navigating EU MDR regulations, ISO13485 and QSR 820.

Experience

  • To make the validation master plans for class IIa and class Im devices. And, discuss the testing conditions with testing laboratories like SGS and UL.

 

  • Cooperated with quality assurance and quality control departments to monitor IQC, OPQC, PQC, FQC, OQC’s data to ensure the device’s quality. Use 5 Why and Fishbone methods to do the Corrective And Preventive Action when there was a complain event which needs to be analyzed. 

 

  • Manage the whole PMS system and re-write the PMS process in our company to fulfill the requirements with MDR regulation.

Education

University of Nottingham Master's degree, Bioengineering and Biomedical Engineering · (August 2023 - September 2024) 

 

Tzu Chi University Master's degree, Department of Laboratory Medicine and Biotechnology · (July 2017 - July 2018) 

 

Tzu Chi University Bachelor's degree, Life Science · (September 2013 - July 2017)

Professionals in the same Engineering / Architecture sector as CHUN-YI CHEN

Professionals from different sectors near Nottingham, Nottingham

Other users who are called CHUN-YI

Jobs near Nottingham, Nottingham

  • Regulatory Specialist

    1 month ago

    Jobster Derbyshire, England

    This is a small, close knit environment where everyone knows each other and your work actually matters. · ...

  • Technical Specialist

    3 weeks ago

    Johnson & Johnson MedTech Leicestershire, England

    We believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. · ...

  • Head of Clinical Professionalism

    1 month ago

    HBSUK Nottingham, England

    Job summary · Head of Clinical Professionalism provides expert professional and strategic leadership for the clinical workforce. · ResponsibilitiesDevelops articulates delivers company's long-term strategy for clinical workforce development education and professional standards. · ...

See jobs in Nottingham, Nottingham