Guide the planning and implementation of the company's quality policy and objectives, promoting quality awareness.
Review and evaluate the development of the Quality Management System (QMS).
Coordinate, advise, and train employees on quality management.
Maintain compliance with Company SOPs and local/global regulations.
Examine and release quality-relevant documents; inform executives about quality data.
Coordinate quality improvement measures and ensure QM verification documentation.
Manage the annual audit program, including auditor selection and internal audits.
Supervise corrective and preventive actions related to systems and products.
Record and evaluate customer complaints in collaboration with the Global Quality Team and authorities.
Attend monthly regulatory and quality calls for follow-up actions.
Plan and execute national approvals and ensure compliance with Turkish market regulations.
Serve as the contact for authorities and maintain close communication with the global regulatory/quality team.
Submit and maintain national medical device registrations, collaborating with authorities and the ZEISS Global Regulatory Team.
Track CPO and NPS.
Coordinate the establishment of a Legal Contract Management system.
Support local occupational health and safety processes in line with global standards.
Conduct ISO 17025 certification and auditing processes.
Experience Requirements
1 - 2 years
Educational Requirements
Bachelor/Honors
Skills
Work experience in a similar position in an international companyVery good command of EnglishVery good command of MS Office ApplicationsConfident with legal issues and medical device law texts (MDD/ MDR)Knowledge of National Product Tracking SystemKnowledge of In Vitro Diagnostic Medical DevicesDirective (98/79/EC) / Medical Device Directive (93/42/EEC) / Medical Device Regulation (2017/745)No travel restrictions for domestic and international