Support daily QC activities across production areas such as assembly, pouching, labeling, and packaging.
Perform and verify line clearance, equipment checks, and in-process inspections.
Record and review production and QC testing data in Device History Records (DHRs) in real time.
Conduct AQL inspections and sampling on finished products as required.
Identify and report non-conformances, assist in root cause analysis, and ensure proper documentation.
Maintain organized records and ensure data archiving in accordance with SOPs.
Assist in training new QC personnel and support cross-functional communication with production teams.
Communicate effectively in both English and Korean to support collaboration across departments.
Qualifications
Bachelors degree in Biology, Chemistry, or a related scientific / engineering field (preferred).
05 years of experience in Quality Control or Quality Assurance within a GMP-regulated manufacturing environment.
Experience in medical device, pharmaceutical, or diagnostics industry preferred.
Bilingual in English and Korean preferred
Working knowledge of ISO 13485, GMP, and FDA quality regulations is a plus.
Strong attention to detail and documentation accuracy.
Ability to work independently and as part of a team in a fast-paced environment.
Excellent time management and problem-solving skills.
Proficiency in Microsoft Office (Word, Excel).
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Quality Control Specialist • Monroe Township, NJ, US
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