Quality Control Inspector

The Inspector performs basic routine inspection of electronic, electro-mechanical and/or mechanical materials, components and sub-assemblies received, in process of manufacture, or manufactured, for conformance with quality assurance standards.

Key

Job Duties and Responsibilities:

Inspection & Testing:
Performs visual and physical inspections of raw materials, in-process components, and finished products to ensure they meet quality specifications. Uses precision measuring tools and lab equipment to verify product dimensions and performance.

Documentation & Compliance:
Accurately maintains Lot History Records (LHR), batch records, and inspection logs in compliance with Good Documentation Practices (GDP) and FDA regulations.

Defect Management:
Identifies, classifies, and reports defects. Manages non-conforming material by initiating Non-Conformance Reports (NCR) and assisting with investigations.

Process Control:
Monitors production processes to ensure adherence to standard operating procedures (SOPs) and Good Manufacturing Practices (GMPs).

Equipment Maintenance:
Calibrates, cleans, and performs routine maintenance on inspection and testing equipment to ensure accuracy.

Collaboration:

Works with production and engineering teams to support quality improvements, provide feedback on product quality, and ensure regulatory compliance.

Attention to Detail:
High level of accuracy in documentation and inspection.

Computer Literacy:
Proficient in using software like SAP, POMS, or Laboratory Information Management Systems (LIMS).

Technical Knowledge:
Understanding of ISO 13485 and FDA 21 CFR Part 820 regulations.

Communication:
Ability to clearly report deviations and collaborate in a team environment.

Common Educational/Experience Requirements:

High school diploma or equivalent is required. Associates or Bachelors degree in a technical field preferred.

Previous experience in manufacturing, particularly in medical device, pharmaceutical, or similar regulated industries is highly desired. 1+ years of experience desired.