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FA | EN

Quality Control Manager

Straumann

MarkaziPosted 4 days ago

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.

Requirements

Education: ● Engineering degree or equivalent ● Knowledge of ISO13484, MDD 93/42 EEC, EU Medical Device Regulation. ● Ability to work in cross-functional, cross-culture teams. Experience: ● 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. Personal attributes: ● Distinct communicative and professional, independent and team oriented work behavior. ● Training skills.

Job Category

  • Quality Control, QA & Inspection

Employment type

  • Full Time

Seniority

  • Manager