Role details
A leading global diagnostic and healthcare solutions company is looking for a Quality Assurance Specialist to support quality system operations and regulatory compliance. We welcome recent graduates and entry-level candidates with a relevant background who are eager to learn and grow in the industry.
Responsibilities
- Support daily QA operations including document control, change control, training, and CAPA management.
- Review and approve production records, quality documentation, and process deviations.
- Assist with internal and external audits by preparing records, reports, and audit responses.
- Maintain Standard Operating Procedures (SOPs), document archiving, and version control.
- Coordinate and track employee quality and regulatory compliance training.
- Support non-conformance and complaint investigations, root cause analysis, and corrective actions.
- Collaborate cross-functionally with QC, Production, and Regulatory teams.
Requirements
- Education: Bachelor’s degree in a scientific, engineering, or related field.
- Experience: 0–5 years of experience in Quality Assurance within a regulated environment (ISO 13485, FDA QSR, or GMP preferred). Recent graduates are encouraged to apply.
- Languages: Fully bilingual in Korean and English.
- Work Authorization: Must be authorized to work in the U.S. without visa sponsorship.
- Skills: Strong attention to detail, solid problem-solving abilities, and proficiency in MS Office (Word, Excel, Outlook).