Quality Control Specialist

Quality Control Specialist

Monroe Township, New Jersey, United States

About the Job Quality Control Specialist

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).