Yun-Hsuan Chen

Quality affairs and regulatory affairs engineer specializing in medical devices. Experienced in quality management and ISO 13485/MDSAP audits, committed to continuous improvement.

QARA Engineer at Braindex (2023-06 – Present)

• Lead the organization through ISO 13485 and MDSAP certification audits within two years.
• Ensure full compliance of the QMS with ISO 13485, ISO 14971, and other applicable standards.
• Monitor and review regulatory updates.
• Define, update, and monitor quality procedures and document control processes.
• Organize and perform internal and external audits (ISO 13485, MDSAP), manage CAPAs, conduct root cause analysis, and coordinate follow-up actions and audit responses.
• Organize and facilitate Quality Management Reviews and maintain risk management processes.
• Manage the Change Control process to assess and mitigate quality and regulatory risks.
• Lead continuous improvement projects across quality and operations.

Researcher at Win Coat Corporation (2018-06 – 2020-02)

Conducted on research in microneedle patches for Hand, Foot, and Mouth Disease, patented in EP, TW, US, JP and CN. Name: Needle base composition for microneedle patch and microneedle patch comprising the same

• Premarket strategy investigation and supplier management.
• Supported the establishment of quality control systems in compliance with ISO 22716 and GMP requirements.

Research Assistant at Formosa Plastics Group (2015-09 – 2016-08)

• Conducted research on super-absorbent polymers and supported product quality optimization.
• Laboratory affairs maintenance.

MSc in Healthcare Business & Clinical Research – University of Lille (2021-09 – 2022-08)

MSc in Biomedical Materials & Tissue Engineering – Taipei Medical University (2020-09 – 2021-08)

BS in Chemical Engineering – Ming-Chi University of Technology (2013-09 – 2017-06)