Quality Assurance Specialist

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Overview Application

LocationOnsite · Jersey City, NJ, US

Employment Typefull time

DepartmentHealthcare

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).

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