Woo Kang Email & Phone Number

Vaughan, ON, CA

Kitchener, Ontario, Canada

• Held authority for quality system and product development compliance. Responsible for setting and implementing quality strategies for the organization and managing the quality system and the functionality of its.
• Launched a point-of-care allergy diagnostic device in the United States. Acquired a 510(k) Premarket Notification and CLIA waiver for the Kenota 1 product, the first of its kind.
• Conducted monthly meetings with department heads to monitor the effectiveness of the quality management system (QMS). Implemented improvements based on feedback and gathered data and corrected any nonconformance.
• Conducted annual management reviews in accordance with ISO 13485:2016 to guide senior management through quality objectives and to report current quality metrics.
• Led the discussions on strategies in obtaining an ISO certification. Performed a cost-benefit analysis to determine the best time and pathway to obtain and maintain the certification. Presented the findings to senior.
• Negotiated with suppliers to reduce 40% in the renewal cost of an eQMS Software.

Kitchener, Ontario, Canada

• Led the Quality Assurance function within the organization under the guidance of the CTO, overviewing product development, driving regulatory compliance, and improving the existing quality management system (QMS).
• Acted as the single point of contact for the Quality Assurance function within the organization. Assessed quality risks and nonconformances for the quality management system and ongoing projects.
• Evaluated several Electronic Quality Management System (eQMS) Software. Performed cost-benefit analyses to determine the best suited eQMS software for the organization and presented the results to senior management to.
• Launched an eQMS software in the organization. Executed the transfer of documentation, the implementation of process workflows, and trained the organization on the use of the new software.
• Improved the QMS through periodic reviews of documentation and employee feedback. Accelerated processes by removing unnecessary burden on users, while reducing noncompliance by restructuring process workflows.

Kitchener, Ontario, Canada

• Built the foundation for a flexible quality management system (QMS) compliant to FDA 21 CFR 820 and ISO 13485:2016 for a small start-up organization where no existing system had been previously established.
• Identified the various international standards for medical device QMS and achieved a working understanding of these standards.
• Explored the various examples of industry standards for the implementation of each major component of the QMS and evaluated each option to build a system suitable for the organization.
• Designed a flexible QMS that could meet the needs of the fast-paced environment and grow with the organization, while remaining compliant with regulatory requirements.
• Authored the documentation (quality manual, standard operating procedures, templates, records, etc.) required for day-to-day use of the QMS.
• Managed multiple projects to ensure the back-end functionality of the QMS ran smoothly such as document control, change control, and training management.

Toronto, Canada Area

• Supported the production engineering team in performing equipment qualifications, verification studies, and process optimizations.
• Coordinated installation and operational qualifications (IQs/OQs) on new manufacturing equipment. Delegated protocol tasks within the technical team to complete the qualifications in the scheduled down-time.
• Performed various verification studies supporting corrective and preventative action (CAPA) closures.
• Designed and implemented a simple system to improve the efficiency of line changeovers between products.

Toronto, Canada Area

• Improved production and changeover efficiency through supporting documentation
• Created training presentations instructing the use of various equipment on the manufacturing floor.
• Accelerated changeover times by creating supporting documentation for each production line. In conjunction with standard operating procedures, these Job Supporting Manuals provided in-depth guidance on production line.
• Edited standard operating procedures to improve clarity and accuracy.

Toronto, Canada Area

• Developed 3D in-paper microfluidic structures for liquid transfer.
• Researched and Designed a surface coating formulation to maximize liquid absorption.
• Design experiments to test the performance and properties of the prototype.
• Assisted in the development of a dye based bio-assay.
• Led the hands-on prototyping of the product for demo day.

Waterloo, Ontario, Canada

• Designed experiments to maximize the physical properties of composite materials.
• Gained extensive experience with injection molding and double screw extrusion.
• Performed impact tests and tensile tests to measure physical properties of materials.
• Analyzed toughness data and tensile strength to optimize formulations.

Toronto, Canada Area

• Assisted the implementation of a cloud-based storage system for patient data at the Toronto Western Hospital.
• Assisted in training the physicians on using the new data entry software.
• Troubleshot unexpected problems during clinic hours.
• Communicated between developers and physicians to meet the needs of the department.
• Bug tested the software during development.