Quality Systems Specialist

Description

• 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

Qualifications

• Bachelor’s degree required in medical, biological science or equivalent field
• Prior experience in a Quality Specialist role is essential with 3 - 5 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