Quality Assurance Specialist

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.

Key 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.

Qualifications

• 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).