Isabelle Ying Email & Phone Number

Singapore

• Played a pivotal role in achieving and maintaining ISO 13285:2016, FDA QSR, EU MDR, and MDSAP certification in the organization-relevant jurisdictions, ensuring adherence to quality standards and regulatory requirements.
• Implemented and maintained Quality Management System (QMS), including the development of Standard Operating Procedures, work instructions, and document control processes, to ensure consistent processes and facilitate.
• Executed investigation of non-conformances, customer complaints, and CAPA (Corrective and Preventive Action) processes.
• Responsible for quality processes such as equipment calibration and maintenance, and incoming, in-process, and outgoing QC inspections to ensure material and product specifications were met.
• Facilitated supplier audits as part of the supplier management process to ensure a high standard of quality in finished goods.
• Conducted training for new hires on QMS awareness.

• Overall maintenance of ISO 13485 Quality Management System, including Change Controls to ensure suitability for departments, and creation of new Quality Procedures as required.
• Facilitated internal and external auditing processes by ensuring all documentation are in compliance with ISO 13485 standard, by which the company has passed its external audit.
• Executed initiatives, including revision of quality procedures and forms, based on collected feedback and Opportunities for Improvement from Internal Audits, External Audits and Management Reviews.
• Developed and implemented Patient Feedback Questionnaire in accordance with Net Promoter Score (NPS) and SERVQUAL to measure patient satisfaction on Surgical Assessment Service provided.
• Collaborated with several departments on types of regulatory submissions and preparation of documentation that were required in situations such as proposed design changes and implementation of software life cycle.

Singapore

• Conducted literature review and complied summaries on verification methodologies of measurement devices.
• Designed suitable test plans and protocols for in vivo trials based on literature review to verify and validate GATOR measurements.
• Applied graphical tools from Excel for data visualisation to analyse sensor data.
• Established acceptable repeatability and reproducibility of GATOR in measuring knee joint angles in healthy subjects.

Singapore

• Identified features from biomechanical data from prototypes and experimental set-ups to objectively measure knee function.
• Developed an algorithm using MATLAB to extract identified features from sensor data.
• Assisted in data acquisition and analysis from clinical studies.
• Created an Excel sheet template to manage inventory during product development.

Bachelor Of Engineering - Be, Bioengineering

Courses In Engineering Communications Ii And Discover Korea: Korean Culture And History

Student Exchange Programme

Diploma, Biomedical Engineering

Diploma Plus Certificate in Korean