Kerja Sepenuh Masa Quality Engineer, Gaji tinggi MYR 4,500 di HCM-Hygenic Corporation (M) Perak - Maukerja

Responsibilities:

• Manage and coordinating the process verification and validation activities, internally and/or with corporate team, according to FDA and all other global regulatory agency requirements.
• Perform supplier selection, qualification and evaluation which include site audit as needed. Monitor supplier performance or corrective/preventive action pertaining to quality issue or failure of incoming inspection.
• Perform and co-ordinating the internal quality audit program and external audit as per schedule. Co-ordinate and close all any corrective/preventive action pertaining to the audit.
• Participate/co-ordinate the design process and new product launches, including Operations training, FMEA and Control Plan development to ensure that expectations for quality, performance, regulatory compliance, and delivery are met.
• Identify areas of improvement within the organization and drive to completion with by establishing partnership with applicable departments. Provide and initiate training programmers to new products and set process parameters.
• Use appropriate quality tools as part of multifunctional team (such as FMEA, and Gage R&R analyses) to solve problems identified during quality assurance activities. Monitor product performance and institute methods to reduce variability.
• Ensure that appropriate testing, measurement, calibration and analytical equipment and methodology is used for quality assessment; serve as a metrology resource.
• Address customer complaints to assure that root cause analysis and proper corrective action/preventive actions are taken, and results are communicated to the customer and all other appropriate parties in a timely manner.
• Assist Management in developing & maintaining the QMS procedures & work instructions in compliance with ISO13485, GMP and other regulatory quality standards.
• Perform failure analysis and ensure that timely corrective/preventive action is taken

Requirements:

• Bachelor degree or equivalent certification preferred.
• 2+ years QA experience, preferably in a corporate environment.
• Knowledge of ISO13485 and FDA requirements for Medical Devices.
• Knowledge of quality management system software application.
• Meticulous, analytical and able to work independently

Pay: RM3,000.00 - RM4,500.00 per month

Benefits:

• Cell phone reimbursement
• Free parking
• Health insurance
• Maternity leave
• Opportunities for promotion
• Parental leave
• Professional development

Work Location: In person