Quality Control SpecialistDHD Consulting • Monroe Township, NJ, US
Quality Control Specialist
DHD Consulting • Monroe Township, NJ, US
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job_description.job_card.job_descriptionBachelors 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).
Job Description
Job Description
Key Responsibilities
- 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
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Quality Control Specialist • Monroe Township, NJ, US
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