•    Change control process management
•    Coordination of change requests and implementation (Design, Production, QMS)
•    Support for product regulatory documentation and IVDR project

계약기간: 입사일~2026.12.31

[자격요건]
•    Bachelor’s degree or higher in science or engineering
•    Proficiency in MS Excel and MS Word
•    English proficiency is mandatory (ability to draft documents and communicate in business English)


[우대사항]
•    Experience in change management within diagnostics or pharmaceutical companies

Essential Duties and Responsibilities
•    Carries out duties in compliance with established business policies and procedures. 
•    Demonstrates commitment to the development, implementation, and effectiveness of applicable Quality Processes as per ISO, IVDR and other regulatory agencies. 
•    Responsibility to understand and maintain awareness of the quality consequences which may occur from the improper performance of their specific job. 
•    Provide compliance oversight and guidance for Change Management activities, as assigned.
•    Ensure compliant documentation, carrying out tasks related to area of responsibility with management oversight.
•    Update and create quality procedures as required through the change control process. Review and approval of quality system procedures.
•    Identifies deficiencies in quality systems and defines systematic corrective actions. Supports the continuous improvement of quality system processes. 
•    Develops effective quality metrics and communicates results to key stakeholders. Preparation and maintenance of records associated with the management review process.
•    Drives compliance cross functionally in alignment with the Business Unit objective for standardization and collaboration.  
•    Perform other duties and projects as assigned.