As a Quality Systems Specialist, you will play a key role in maintaining and advancing the Quality Management System (QMS) across Korea operations. Your work will ensure adherence to Korean medical device regulations, ISO 13485 standards, and global quality policies, supporting both compliance and continuous improvement goals.
Key Responsibilities
- Ensure the local QMS aligns with Korean regulatory requirements and international standards
- Maintain and update quality procedures, documentation, and records in coordination with global guidelines and local practices
- Develop and manage training plans using the learning management system to support team competency
- Lead internal audits and drive corrective and preventive actions to address findings
- Support Post Market Surveillance activities, including random inspections, unannounced audits, and regulatory reviews by MFDS
- Oversee supplier and distributor quality performance and compliance
- Manage change control processes and risk assessments across quality systems
- Lead or contribute to local and APAC-wide initiatives aimed at enhancing quality performance
- Process product complaints, adverse event reports, and foreign material notifications in line with regulatory timelines
- Execute Field Corrective Actions and coordinate with global teams to align with enterprise quality strategy
Qualifications
A bachelor’s degree in a medical, biological, or related scientific field is required. Candidates must have 3–5 years of experience in quality assurance, preferably within the medical device industry. Familiarity with QARA operations, KGMP audit practices, and Class IV medical devices is highly valued. Proficiency in both English and Korean is essential for effective communication.
Strong organizational, problem-solving, and documentation skills are critical. Experience with MS Office and learning management systems is expected. The ideal candidate works effectively both independently and within cross-functional teams, demonstrating a commitment to accuracy, compliance, and continuous improvement.
