Reporting to the Quality Systems Supervisor, the Senior Quality Systems Specialist will handle the QMS, GMP and PMV operations to ensure the company is operating and meeting the established quality standard of medical devices across all business. 

This is a rare and incredible opportunity to enhance your skillset in supporting our market leading technology across a broad range of products.

Responsibilities may include the following and other duties may be assigned:

• Ensure Korea QMS follows Korea medical device regulation and ISO 13485

• Maintain QMS procedures and quality records to align with global policies, local regulation, and local practice

• Establish training matrix and assign training in learning management system

• Conduct internal audit and corrective and preventive actions

• Prepare and support Post Market Surveillance audit (e.g., Random product inspection, Unannounced surveillance inspection, Special inspection from MFDS etc.)

• Manage distributors and suppliers

• Manage change control and risk management 

• Participate and own local/APAC project for continuous improvement

• Handle Product Complaint 

• Handle Adverse Event Reporting, Oversee Adverse Event Reporting and Foreign Material reporting

• Execute Field Corrective Action (FCA)

• Collaborate with global complaint and FCA team for Enterprise quality strategy 

Required Knowledge and Experience:

• Bachelor’s degree required in medical, biological science or equivalent field

• Prior experience in a Quality Specialist role is essential with 6+ years of relevant experience, preferably medical devices. 

• Good understanding and working knowledge of QARA Operations

• Effective written and verbal communication skills in English and Korean languages 

• Strong ability to work well within a team and autonomously

• Achievement oriented and ability to drive results with the highest quality standards

• Computer skills (excellent knowledge of MS Office products)

• High attention to detail and accuracy

• Good prioritization and organizational skills

• Excellent problem-solving skills

• Korea Good Manufacturing Practice (KGMP) onsite audit and Medical devices class IV product handling experience is highly regarded