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Quality Control Specialist

Quality Control Specialist

DHD ConsultingMonroe Township, NJ, US
18 hours ago
Job type
  • Full-time
Job description

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

  • 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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