Quality Control Manager

Job Description

● Provide quality and regulatory support for product life cycle, especially for change management, be the liaison with design centers to receive and implement change or to re-quest change. ● Be responsible for the maintenance of the site Master file (unique dossier which describe the production site with process, process control. ● Collaborate with manufacturing and other functions to ensure that compliance quality standards and Good Manufacturing Practices are met and maintained. ● Develop required organizational processes and competencies. ● Ensure that the conformity of devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released. ● Ensure that all documents required to satisfy applicable regulatory requirements are implemented, applied, maintained and complete. ● Ensure that all activities required by the applicable regulatory requirements are implemented and appropriately documented (e.g. equipment qualifications, process validations, risk analyses and etc.) ● Develop and monitor appropriate metrics to track quality and process improvement. ● Develop and control budget for its organization.