Quality Assurance Inspector

Job Category: Engineering
Job Type: Full Time
Job Location: Mishawaka and Plymouth IN

The QC Inspector will be responsible for performing inspection on medical devices to specified requirements to determine product disposition. Will operate in accordance with company procedures, FDA Regulations, ISO 13485;2016 and other applicable requirements.

Job Description:

  • Completes routine and complex inspections using applicable
    sampling plans/control plans to verify product and services
    conform to quality and other engineering and Quality Assurance
  • Performs visual and dimensional inspection, and functionality of
    medical devices.
  • Performs pt Piece inspections at the beginning of jobs for
    machine operators and approves or identifies non-conforming
    measurements of pt Piece.
    Identifies and documents potentially non-conforming product.
  • Ensures non-conforming product is properly segregated and
    Interfaces with other departments, to address and resolve
    product related issues.
    Reads, understands, and follows company procedures, policies,
    and work instructions.
  • Moves product to the correct department according to the flow
    of job travelers.
  • Maintains accurate inspection records, filing systems and
    appropriate documentation to conform to all quality regulations.
    Operates CMM as needed.
  • Uses computer and different computer applications/programs
    for each job/project.

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