Job Details

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.

Key Competencies:

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.