Cathleen Kung

Quality Assurance Technician @ Osteopore (OSX.AX)

About

Biomedical engineering professional with 5+ years of experience spanning quality assurance, regulatory compliance, and manufacturing operations in the medical device industry. Expertise in ISO 13485, MDD/MDR compliance, supplier audits, QMS remediation, cleanroom operations, and training. Hands-on experience in SolidWorks, 3D printing, QC, and environmental monitoring. Proven ability to optimize processes, strengthen audit readiness, and lead training programs that drive compliance. Experienced in Cleanroom Class 7 (ISO Class 10,000) environment.

Country

Singapore

City

Singapore

Industry

Medical Device

Skill

Auditing, Quality Control, External Audits, Quality Auditing, Quality System, Microsoft Office, Microsoft PowerPoint, Microsoft Excel, Quality Management Systems (QMS), Internal Audits, Root Cause Analysis, Communication, Organization Skills

Experience

Quality Assurance Technician

Osteopore (OSX.AX)

2019-5 - 2024-12 · 5 yrs 8 mos

Singapore, Singapore

•Maintained organization's Quality Management System (QMS). •Planned and conducted internal audits to ensure compliance with ISO 13485 standards and QSR •Planned and conducted supplier quality audits for critical suppliers to ensure compliance with quality standards. •Planned and supported operational activities to ensure timely delivery of products to customers. •Lead Complaint, CAPA and NCR investigations •Planned and executed supplier qualifications, routine monitoring and training programs. •Planned and conducted quality inspection on raw material, in-process products, and finished goods and ensured inspection results meet specifications before release. •Planned and conducted training for production operators to ensure awareness and compliance to organization's SOP, and product inspection specifications. •Prepared, supported and successfully passed external audits and inspections from EU Notified Body audits (including audits for MDR). •Prepared, supported FDA inspection •Participated in discussions with a consultant for organization’s QMS remediation, planned and executed remediation of QMS. •Supported and Participated in Risk Management activities. Certifications: ISO 13485:2016 Internal Auditor