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 13485regulated 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.
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