The Company develops, manufactures, and markets in-vitro diagnostics (IVD) tests.
 

Experienced Quality Assurance professional with 5-7 years in the medical device industry, focused on audit response, CAPA, validation, and document control within ISO 13485-compliant environments.
 

• Prepare and maintain the quality system in a state of audit readiness. 
• Lead internal preparation and documentation support for regulatory, customer, and certification audits (e.g., ISO 13485/cGMP/MDSAP/IVDR/WHO PQ). 
• Respond to auditor inquiries and ensure timely resolution of findings.
• Manage the full lifecycle of Corrective and Preventive Actions (CAPA), including root cause analysis, implementation of corrective actions, effectiveness checks, and documentation. 
• Collaborate with cross-functional teams to ensure long-term compliance and quality improvements.
• Lead and coordinate equipment, process, and software validation activities. 
• Ensure proper planning, protocol development, execution, deviation handling, and reporting are in compliance with regulatory requirements and internal procedures.
• Oversee creation, revision, approval, and archiving of controlled documents including SOPs, work instructions, forms, and quality records. 
• Ensure alignment with document control policies and support training on new or revised procedures.
• Support the implementation and monitoring of QMS elements (ISO 13485). 
• Lead quality initiatives and gap assessments, and drive continuous improvement through internal audits, KPI monitoring, and quality review meetings.
   

• Bachelor's degree in Biomedical Engineering, Biotechnology, or a related field in life sciences or engineering
• Minimum of 5–7 years experience in Quality Assurance within the medical device or pharmaceutical industry, including audit preparation, nonconformance handling, and quality system maintenance
• ISO 13485 Internal Auditor certification (preferred)
• RCC-MDR or equivalent regulatory training (preferred)
• English and Korean bilingual (preferred)
• In-depth understanding of ISO 13485 and QMS requirements
• Experience with CAPA systems, validation protocols (IQ/OQ/PQ), and document control procedures
   

• Health, Dental, and Vision
• Paid Time-Off
• 401(k)
• Incentives