Quality Assurance Engineer
Merasenko Corporation
Mactan Economic Zone Ii, Cebu Philippines
Japan Equipment & Disposal Manufacturing and Sales Medical Products Devices Company for following clinical fields: Anesthesia (anesthesia apparatus, tracheostomy tube, breathing circuit,etc) Cardiovascular surgery (heart-lung machine, membrane oxygenerator, intra-aortic balloon pumping machine, balloon catheter,etc), Operating room & ward (electrical surgical unit, continuous suction unit, sponge counter, etc), Orthopedics (retractor, etc). Review and evaluate adequacy of system in place to maintain test ISO 13485, ISO 9001and ISO 14001 certificates obtained Monitor and maintain the quality of the product and process of medical devices Conducts periodic internal and supplier audit for continuous quality and system improvements Responsible for all QC activities, develop and implement incoming, in-process and outgoing inspection standards, procedures and work instruction Responsible for the process of ETO and STEAM Sterilizer Chamber. Handle all Quality issues related to the process and product Work closely with suppliers and customers regarding quality issues Performs thorough investigation on nonconforming products and customer complaints Follow-up and resolve Corrective and Preventive actions formulated from issues by suppliers, internal audits, external certifying bodies and customer complaints Used QC Tools, FMEA, Cp&Cpk, X-bar R to solve a problem in production area Coordinate with other departments in the preparation of defect reduction and cost cutting measures. Provide quality engineering support to production and ensure conformance to customer specification and requirement Provide Basic Statistical Process Control (SPC) Monitor and maintain the quality incoming parts using the given standard Supervise and train incoming inspector Responsible in quality management system (QMS), management responsibility, resource management, product realization, measurement, analysis and improvement