Quality Control Specialist

Job Title: Quality Control Specialist

Work Location: Middlesex County, New Jersey

Summary:

The Quality Control Specialist is responsible for supporting quality control activities throughout various production processes, ensuring compliance with regulatory standards, and maintaining accurate documentation. This role involves performing inspections, verifying equipment, and collaborating with production teams to uphold product quality.

Responsibilities:

• Oversee and support daily quality control activities across multiple production stages, including assembly, labeling, and packaging.
• Conduct and verify line clearance, perform equipment checks, and execute in-process inspections to ensure compliance.
• Accurately record and review production and quality control testing data in Device History Records in real time.
• Carry out AQL inspections and sampling procedures on finished products as required by protocols.
• Identify, document, and report non-conformances, assist with root cause analysis, and ensure corrective actions are implemented.
• Maintain organized records and ensure proper data archiving in accordance with established standard operating procedures.
• Assist in the training of new quality control personnel and facilitate effective communication with production teams.
• Support cross-functional initiatives to enhance quality processes and ensure regulatory compliance throughout production.

Qualifications:

• Bachelor’s degree in Biology, Chemistry, or a related scientific or engineering field preferred.
• 5+ years of experience in Quality Control or Quality Assurance within a GMP-regulated manufacturing environment.
• Experience in the medical device, pharmaceutical, or diagnostics industry preferred.
• Bilingual proficiency in English and Korean preferred.
• Working knowledge of ISO 13485, GMP, and FDA quality regulations is a plus.
• Strong attention to detail and accuracy in documentation.
• Ability to work independently and collaboratively in a fast-paced environment.
• Excellent time management and problem-solving abilities.
• Proficiency in Microsoft Office applications, including Word and Excel.

Published Category: Quality & Validation