Matthew Ong

Experience

• 

  Immunicom, Inc.

  Jun 2014 - now

  Reporting to the Vice President of Quality, I am responsible for overseeing all aspects of Quality Control and driving continuous improvement with a quality-first mindset. I lead various design and development activities, risk analysis initiatives, CAPA management, nonconforming material and product investigations, and other critical quality and regulatory processes. Additionally, I provide guidance and training to QC personnel in the control, testing, and documentation of raw materials, components, and finished products. These products incorporate a wide range of validated processes and materials, including biocompatible polymers, biological components, sterile-barrier packaging, cold chain monitoring and shipping, environmental control and monitoring, terminal sterilization (E-beam, gamma radiation), and sterility monitoring processes.Internal Audit Management: Led the internal audit program, reviewing evidence, documenting findings, and ensuring compliance with internal and external regulatory requirements.Regulatory Compliance & Certification: Played a key role in three Notified Body certification and surveillance audits, contributing to the achievement and maintenance of ISO 13485 certification, MDR, and CE mark approvals.Process & Documentation Development: Established and maintained protocols, procedures, training programs, and documentation covering raw material to final product testing, as well as process and equipment validations.Product & Process Improvement: Led product and process design changes and risk analyses, enhancing product safety and optimizing manufacturing efficiency.Environmental Monitoring: Developed and managed environmental monitoring programs for critical environments, including microbiological monitoring of cGMP production areas (ISO Class 7 cleanrooms) and testing facilities. Show less As the Quality Control (QC) Supervisor, I was responsible for overseeing the control, testing, and analysis of raw materials, in-process materials, and final products in a GMP-compliant environment. I actively collaborated on product development activities for medical devices and played a key role in the creation and maintenance of documentation related to product development, manufacturing, and testing processes for products supporting both clinical trials and commercial initiatives.Personnel Training & Coordination: Trained QC personnel and coordinated all QC-related activities to ensure compliance and efficiency.Stability Program Management: Led the stability program for final products and critical raw materials, ensuring product integrity and regulatory compliance.Project Management: Oversaw the establishment of cytokine analysis capabilities in Poland to support clinical trials. Managed production and testing facility renovation projects (ISO Class 7 Cleanroom) to enhance operational efficiency and compliance. Led the implementation and management of environmental monitoring programs and systems for manufacturing facilities.Cross-Functional Collaboration: Worked closely with the Design and Development Team and the Material Review Board to support product quality and innovation.Regulatory Certification & Compliance: Worked collaboratively with all internal departments to successfully obtain CE Mark and ISO 13485 certification for a Class IIb medical device, ensuring compliance with international regulatory standards. Show less As a QC Chemist, I was responsible for the sourcing, analysis, and control of raw materials, in-process samples, finished products, and stability samples. I contributed to early product development efforts for medical devices and pharmaceutical products, ensuring quality and compliance with regulatory standards.Advanced Analytical Testing: Performed complex cytokine sample analysis on pre-clinical plasma studies.Regulatory Documentation: Authored and maintained documentation related to the development, testing, and manufacturing of drug and medical device products.QC Testing Oversight: Managed QC testing for products used in pre-clinical and first-in-human safety studies.Laboratory Operations Management: Maintained laboratory inventory, coordinated shipping and receiving activities, and ensured general laboratory cleanliness and pest control compliance.Facility Development & Expansion: Led the setup of production and testing laboratories in California and Mexico, ensuring operational readiness and regulatory compliance. Show less

  • Quality Manager

    Feb 2022 - now

  • Quality Control Supervisor

    Sept 2018 - Feb 2022

  • QC Chemist

    Jul 2016 - Sept 2018

  • Internship

    Jun 2014 - Jun 2016