● 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.
● Engineering degree or equivalent
● Knowledge of ISO13484, MDD 93/42 EEC, EU Medical Device Regulation.
● Ability to work in cross-functional, cross-culture teams.
● Significant experience in Quality Management in Medical Devices or Pharmaceutical industry for manufacturing (5 to 10 years).
● Demonstrated experience in people management.
● Problem solving skills (root cause analysis).
● Interaction with authority.
● Distinct communicative and professional, independent and team oriented work behavior.
● Training skills.