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.

Requirements

- Bachelor’s degree in Biology, Chemistry, or a related scientific/engineering field (preferred).
- 5 years or more 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 Required.
- 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).