Quality Assurance Specialist

About the job Quality Assurance Specialist Key Responsibilities Support daily QA operations related to document control, change control, training, and CAPA management. Review and approve production records, quality documentation, and deviations in compliance with internal procedures. Assist with internal and external audits by preparing records, reports, and responses to findings. Maintain and update Standard Operating Procedures (SOPs) and ensure proper document archiving and version control. Coordinate and track employee training to ensure compliance with quality and regulatory requirements. Support nonconformance and complaint investigations, assisting in root cause analysis and corrective actions. Collaborate with QC, Production, and Regulatory teams to ensure cross‑functional compliance and communication. Monitor quality metrics and support continuous improvement initiatives within the Quality Management System. Communicate effectively in both English and Korean across teams and departments. Qualifications Bachelors degree in a scientific, engineering, or related field. 05 years of experience in Quality Assurance or Quality Systems within a GMP or ISO 13485‑regulated environment. Experience in medical device, pharmaceutical, or diagnostics industry preferred. Bilingual in English and Korean preferred. Knowledge of ISO 13485, FDA QSR, and GMP regulations preferred. Strong attention to detail and documentation accuracy. Good understanding of quality processes and regulatory principles. Ability to manage multiple priorities and meet deadlines. Excellent interpersonal and written communication skills. Proficiency in Microsoft Office Suite (Word, Excel, Outlook). Team‑oriented mindset with strong problem‑solving skills. #J-18808-Ljbffr