주요 업무

Key Responsibilities Support the implementation, maintenance, and continuous improvement of the QMS in accordance with ISO 13485 and applicable regulatory requirements. Conduct and document internal audits, process inspections, and product quality checks to ensure compliance throughout the manufacturing cycle. Manage and investigate non-conformances, deviations, complaints, and CAPA (Corrective and Preventive Actions) processes. Assist in the validation and verification of manufacturing processes, equipment, and software used in product realization. Liaise with cross-functional teams (R&D, Regulatory Affairs, Production) to integrate quality requirements into product development and lifecycle management. Maintain accurate quality documentation, including batch records, change controls, and quality reports. Support training of staff on quality standards, procedures, and regulatory requirements. Participate in external audits and regulatory inspections, preparing required documentation and following up on findings. Monitor key quality metrics (e.g., defect rates, customer complaints) and contribute to continuous improvement initiatives.

자격 요건

Qualifications and Skills Bachelor’s degree in science, engineering, or a related field. 2–5 years of experience in quality assurance or quality engineering within the IVD, medical device, or pharmaceutical industry. Working knowledge of ISO 13485, regulatory requirements (e.g., FDA, IVDR), and quality management principles. Experience with CAPA, internal audits, process validation, and documentation management. Strong organizational, communication, and problem-solving skills. Ability to work collaboratively in cross-functional teams.

우대 사항

- Experience with preparing and managing QMS documents - Excellent communication skills - Korean TOPIK Level 5 or higher

선호 비자

복리 후생