Quality Inspector I

Quality Inspector I performs inspections on medical device components, sub-assemblies, and finished products in accordance with FDA regulations and ISO standards. The role involves conducting receiving, in-process, and first-article inspections, maintaining quality records, and supporting cleanroom operations at a New Jersey manufacturing facility.

Responsibilities

• Perform incoming, in-process, and first-article inspections using measuring and test equipment
• Interpret drawings, specifications, and sampling plans to determine material acceptance or rejection
• Maintain accurate inspection records including Material Certifications and Certificates of Conformance
• Conduct inspections in classified cleanrooms and perform line clearances during manufacturing
• Assist in training new associates on Quality System Regulations and standard operating procedures

Requirements

• High school diploma
• QA experience in medical device industry preferred
• Working knowledge of ISO 13485, 21CFR820, FDA QSR, and cGMP preferred
• Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) preferred
• Strong attention to detail, organizational skills, and problem-solving ability
• Ability to work independently with minimal supervision
• Must pass visual acuity test; vision aids permitted if worn during inspections

Compensation: $19.19 - $25.43 USD hourly