Quality Control Specialist

1 week ago


Monroe Township, United States DHD Consulting Full time

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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