• Manage 3PL : Responsible to operate 3PL warehouse aligned with Teleflex’s QMS (PI, PO, 3PL KPI
management etc)
• Implement and manage the Labelling Control Systems to compliment regulations
• Perform review and file in-bound, in-progress and out-bound test reports and keep track of incoming
products and releasing list based on WMS.
• Work with the global customer complaint team to manage, monitor and handle the customer complaints,
product shiphold, recall, rework, etc QMS management and to support the QMS activities
• Maintains and analyzes problem logs to identify and report recurring issues to quality assurance
management
• Support all quality internal/external (MFDS) audits as required
• Completes quality audits and ensures appropriate corrective action is directed and implemented.
• Be responsible for the implementation and verification of CAPA and NCs
• Maintain of Nonconformity log for reporting Global MRB Meeting by monthly
• Update and train staff on all policies and regulations relating to QA (GSP)
• Manage UDI project and submit UDI data to MFDS database
• Responsible for the establishment, execution, maintenance and Global Harmonization of the quality
management system (QMS)
• Manage quality manual, local standard procedure and device master file
• Develop or update company complaint and non-conformity procedures to ensure capture and report, as well
as proper documentation of complaints.

• Professional degree/diploma in Quality/ Engineering/ Science/ Technical field
• Minimum 8 years quality experiences in medical device industry
• Experience in Agile, Viva vault and SAP
• Ability to communicate and network key contacts (MFDS, NB, HIRA, KMDIA etc.) and the Academic Society
• Ability to determines methods and procedures on new assignment and may coordinate activities of other personnel independently. Can operate and drive result and set priorities with limited supervision.
• Having tactics to work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
• Exercises judgement in selecting method, techniques and evaluation criteria for obtaining result.
• Distills complexities and meets the audience where they are. Effectively tailors communications to meet the needs of caring audiences.
• Routinely provides impactful and influential presentations or other knowledge-sharing activities with cross-functional audiences.
• Team player with diversity, equity and inclusion mindset.
• Pragmatic and able to think and operate inter-departmentally and not lose sight of priorities in the hectic day-to-day operations
• Possess a high level of communicative skills, the ability to persuade and self-assertion (in Korean & English)
• Ability to work under pressure analytically and systematically
• Quick comprehension, thinking in terms of the big picture and organizational skills
• Passionate, proactive and a great sense of responsibility