1.1 Overall in-charge of the QA Department. Fully responsible on the smooth running of Product Quality Control (PQC), Material Quality Control (MQC), Quality Management System (QMS) and Calibration section in improving the product quality, efficiency and cost effectiveness of the production operation. 1.2 Appointed as QMR (Quality Management Representative) on overall quality management towards ISO 9001 & ISO 13485. 1.3 Ensure manpower in all levels of QA operations are clear on role & responsibilities and are well trained in skills and knowledge. 1.4 Coach and mentor subordinates to improve skills, competencies and knowledge in order to discharge their responsibilities fully, effectively and timely. 1.5 Ensure system, processes and specifications employed meet customer and regulatory requirements. 1.6 Address CAPA deficiencies arising from audits, noncompliance arising from in process or shipment failure and customer complaints with special focus on effective corrective action and sustainable preventive action. 1.7 Maintain and improve the quality management system to ensure compliance to FDA Quality System Regulations, ISO 13485 Requirements, ISO 14971, Canadian CMDCAS, Japan PAL Regulation, Medical Device Directives and all other worldwide medical device quality regulations. Arrange the internal quality audit and management review.
Professional Latex was established in 2014 with core activities in glove production, specializing in manufacturing latex examination and nitrile gloves.
Bachelor's or Equivalent
