[의료기기/품질관리] RAQA Specialist

A foreign medical device company is looking for an RAQA Specialist. The chosen applicant will be responsible for overseeing quality and regulatory activities, particularly in managing a 3PL warehouse.

Responsibilities:

• Manage 3PL warehouse operations
• Implement and manage the Labelling Control Systems to comply with regulations
• Work with the global customer complaint team to handle customer complaints, shiphold, recall, rework, and support QMS activities
• Maintain and analyse problem logs to identify and report recurring issues to quality assurance management
• Complete quality audits and ensure appropriate corrective actions are implemented
• Be responsible for the implementation and verification of CAPA and NCs
• Manage the UDI project and submit UDI data to the MFDS database
• Maintain Nonconformity log for Global MRB Meeting, reporting monthly

Requirements:

• Professional degree or above in quality, engineering, science, or technical field
• More than 7 years of quality experience in the medical device industry
• Experience in Agile, Viva and SAP
• Ability to communicate and network key contacts (MFDS, NB, HIRA, KMDIA, etc.) and the Academic Society
• Proficient in Korean and English

About the Company:

A multinational medical device company serving a broad range of clients in the healthcare industry. With tens of thousands of people in the global workforce, the company is committed to developing the best products and technologies to serve patients and their healthcare providers better.

Keywords:

의료 기기, 규제 업무, 품질 보증, 엔지니어링, 기술, 국제적

Job Ref: UK7MCO