Key Responsibilities 
 

In the EP/NV Quality assurance, Quality& Regulatory Compliance, based on compliance with laws and regulations and internal regulations (J & J Standard, etc.) and the quality management system, establish the system and manage and supervise the overall QMS system, including the management of NC/CAPA, Internal Audit management, Quality system management review,　Record management and audit response. In addition, he/she shall accurately grasp the needs of customers and businesses, build a good, trusted relationship with each FC, 3 rd party, and stakeholders (including overseas), and establish more efficient QMS business processes. 
 

Experience and Skills: 

Required: 

• Knowledge and practical experience of laws and QMS ministerial requirements  

• Proactive approach/ Able to appropriately demonstrate unique initiatives 

• Logical Thinking, Decision Making, and Problem-Solving Skills 

• Has a strong commitment to achieving goals and a flexible ability to execute. 

• Excellent written and oral communication skills among government, 3 rd parties, organizations, and individuals. 

• Business level English proficiency (Conversation, reading and writing) 

• Project and Team Leadership 

• Ability to multitask. 
   

Preferred: 

• At least 3 years of experience in quality system/quality assurance/quality control and safety management. (This is acceptable if you are in the pharmaceutical or medical device industry) 

• Internal/External Audit Implementation and Response Experience (QMS Auditor License Holder) 

• Experience in the cross-culture/global environment 

• IT/Digital literacy  
   

Education: 

• Bachelor's degree or educational equivalent (Health science or other directly related field or equivalent combination of education is preferred).