Chun Yoong Wei Email and Phone Number

- Works in collaboration with Management to update QMS documentation and records, work instruction, etc. to comply with recent interpretations of the quality system requirements.- Perform the quality assurance function such as establishing implementation and quality guideline and procedure.- Implementing policies, standards, and procedures for complaint handling- Managing customers complaints and developing corrective actions and preventive actions (CAPA)- Managing customer's expectations and handling objections- Preparing 8D/CAR reports summarizing findings and corrective actions.- Manage and monitor the resolution of customer complaints and shipment failure.- Review of replies / feedback to customer complaints prior to final approval by superior.- Understand and interpret customer standards in relation to the work of the organization.- Create procedures and forms based on the understanding of the process and in relation to the QMS requirements along with customer-specific requirements to ensure compliance with the standards.- Identify the defect and find out the actual root cause, improvement, corrective action and support process in troubleshooting.- Facilitate and promote the use of appropriate problem-solving techniques for effective root cause analysis and successful corrective action.

-Join UG Global Resources Sdn. Bhd. (Owned by UG Healthcare Corporation Limited) as an Assistant QA Manager in July 2019, transferred and promoted to QA Manager (QMS) of N.S. Uni-Gloves Sdn. Bhd in April 2021.-Oversee the Quality Management System according to ISO 9001 & ISO13485 Standards and applicable statutory and regulatory requirements (US FDA, MDD, MDR, MDA). -Authorized to amend all the Quality Management documents and procedures in line with the company's policies and objectives. -Prepare product conformity and QA reports that are requested by customers, e.g. Pre-shipment reports, product testing reports, product specification, MSDS and product/service agreements. -Compile internal quality control reports, create statistical process control metrics, manage nonconformity material discrepancy reports, and recommend continuous improvement activities. -Assist to plan, organize, initiate and record periodic factory-wide Internal Quality Audits at all manufacturing sections/functions. Initiate Corrective or Preventive actions for continual improvement. -Assist to prepare and maintaining Technical File and Declaration of Conformity for Latex and Nitrile examination gloves. MD Rule 5, Class 1 (Medical Device Directive 93/42/EEC).-Assist in establishing, maintaining and updating Technical Documentation and GSPR for Latex and Nitrile examination gloves. MD Rule 5, Class 1 (Medical Device Regulation (EU) 2017/745).-Assist in establishing, maintaining and updating the risk management analysis file and its related documents. -Assist to prepare, record and submit new gloves samples for customer evaluation. -Ensure appropriate maintenance and routine calibration of controlled devices and equipment in the factory. -To arrange/to conduct supplier/subcontractor audits.-Assist in all quality audits and inspections to be conducted by 3rd party (ISO audits, pre-registration audits, SGS audits, customer audits, etc.-Handle local/overseas customer complaint/feedback.

-Establish new sets of QMS according to ISO9001:2015 requirements. -Establish Risk Assessment Report for all the departments.-Responsible for effective Quality Management System and ISO procedures compliance to ISO9001 and customer requirements.-Dedicated as the leader for internal and external audits.-Plan the audit plan, execute the audit, prepare audit reports, review audit reports, and raise NC/OFI, follow up on the closure of NC/OFI.-Reports internal & external audit status during Management Review.-Maintain and update new QMS.-Maintain and update Organization Chart.-Create new forms and document registration.-Create and review process flow of manufacturing of commercial food service equipment and departmental process flow.-Follow up activities related to internal, external and customer audits.-To monitor and verify the implementation of suitable corrective and preventive action.-Initiate and coordinate preventive measures through review and analysis of complaints from customers and internal quality issues for continuous quality improvement.-Work interactively with production, sales, customer and purchasing to seek improvement on quality issues and productivity.-Lead, supervise and motivate QA teams to achieve quality objectives.-Appointed as Deputy Quality Management Representative.

-Ensure quality related issues and customer feedback are promptly resolved through effective corrective action.-Responsible for effective Quality Management System and ISO procedures compliance to ISO9001, ISO 13485, ISO14001, FSC, GMP and GDPMD requirements.-To monitor and verify the implementation of suitable corrective and preventive action.-Initiate and coordinate preventive measures through review and analysis the complaints from customer and internal quality issues for continuous quality improvement.-Work interactively with production, sales, customer and vendor to seek for improvement on quality issue and productivity.-Lead, supervise and motivate QA teams to achieve quality objectives.-Organize audit schedule (internal & external). Assigned as auditor upon training and qualification.-Dedicates as leader for internal and external audits.-Plan the audit plan, execute the audit, prepare audit reports, review audit reports, and raise NC/OFI, follow-up on the closure of NC/OFI.-Reports internal & external audit status during Management Review.-Malaysia MDA Medical Device Registration for various brand of thermal paper recording Medical Chart (ECG) and Video Printer Paper (Ultrasound).-EC Certification for thermal paper thermal paper recording Medical Chart (ECG) and Video Printer Paper (Ultrasound).-Maintain and update Technical Files of medical devices. Medical device Class 1, rule 1(Medical Device Directive 93/42/EEC and 2007/47/EC) or Class A, rule 4 (Medical Device Regulation 2012).-Established and implement Out-going Inspection procedure.-Establish control plan, process flow, data analysis for high-end and high-volume product.

-Implement and maintain the Quality Management System, ISO13485 & ISO 9001, of the company.-Ensures overall compliance with ISO 13485, ISO9001, ISO14001, GMP, GDP, Company and regional quality standards-Plans, leads and executes internal audits on ISO13485, ISO9001, GMP and GDP compliance. -Participates in internal and external quality audits.-Lead internal audit team.-Coordinate external and customers audits related to Quality Management System.-Follow up all internal, external and customer audits.-Assist in continual improvement activities to enhance the quality system, such as 5S, Kaizen, etc.-Ensure that Quality Objectives are set by Top Management for measuring the performance of the QMS and these are regularly reviewed.-Create and maintain company Quality Manual, Policy, Objectives, Procedures & Forms are properly documented, controlled and promoted throughout the organization.-Maintain and update medical device file of disposal medical device (plastic needle cover, catheter hub, catheter wing, injection port cap).-Ensure all department documents are maintained in a manner which ensures latest revision and availability at necessary points of use.

-Perform the daily activities associated with supervising a group of QA/QC, supervise and participate in activities associated with production quality issue.-Oversee the quality functions including in-coming, in-process, out-going and customer satisfaction.-Coordinates with production and other department on any quality issue.

-Planning and propose new publication series/ titles of academic/ reference book/ work book for primary and secondary level on Mathematics subject.-Ensure all publication projects are completed based upon the publication schedule.-Sourcing writers for the reference book/ work book/ model test paper of primary and secondary level.-Coordinate and liaise closely with writers to setting the deadlines and specification for the writing of a manuscript.-Coordinate and liaise closely with editors to setting the deadlines and specification for the editing of a manuscript, discuss book format and contents.-Monitor the development of writing based on the agreed-upon submission schedule.-Liaise with Production Department/DTP supervisor on sample layouts.-Liaise with Marketing Department for feedback on released title.