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 training.• 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 processes.

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