About the Role
The Quality Assurance Specialist will support quality system operations and regulatory compliance in accordance with ISO 13485, FDA, and GMP standards.
Key Activities
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.
Preferred Skills
Bilingual in English and Korean preferred
Knowledge of ISO 13485, FDA QSR, and GMP regulations preferred.
Strong attention to detail and documentation accuracy.
Education and Experience
Bachelor’s degree in a scientific, engineering, or related field.
0–5 years of experience in Quality Assurance or Quality Systems within a GMP or ISO 13485–regulated environment.
Experience in the medical device, pharmaceutical, or diagnostics industry preferred.
About Us
Finding a great opportunity that fosters growth, a great culture, and leadership opportunities can be difficult. Top Quality Recruitment (TQR) connects professionals with leadership opportunities across the Packaging, Food and Beverage, Medical Devices, and Biotechnology industries. With 50+ years of experience, we believe in one-to-one communication and finding the best candidate/employer match possible.
TQR is an equal-opportunity employer that encourages diversity. We will consider all applications.
Accommodation for applicants with disabilities is available upon request.
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