4h ago

Quality Analyst - 2nd Shift

Vandalia, Ohio, United States
full-timemedical device

Tech Stack

Description

You will perform quality control inspections and dispositions of materials and products, ensuring compliance with FDA, OSHA, and ISO standards. This role involves reviewing batch production records, tracking CAPA and NCR records, and supporting environmental monitoring programs.

Requirements

  • High school diploma with 0-2 years relevant industry experience
  • Bachelor's degree in life science or engineering preferred
  • Experience in FDA-regulated environment preferred
  • Familiarity with ANSI/ASQ Z1.4-2003 and AQL methodologies preferred
  • Experience with Microsoft Excel and writing SOPs

Responsibilities

  • Perform QC inspections of materials and products using measuring instruments
  • Review batch production records and manufacturing records for lot release
  • Coordinate and track CAPA, NCR, and Deviation records
  • Coordinate and track site environmental monitoring testing program
  • Assist in root cause analysis for quality events
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