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Quality Control Inspector (Medical Device / Manufacturing) (Webster)

Quality Control Inspector (Medical Device / Manufacturing) (Webster)

Insight GlobalWebster, TX, US
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RESPONSIBILITY AND AUTHORITY

This position is responsible for performing incoming inspections on raw components used during manufacturing of in-process subassemblies and finished products.

PRIMARY ACTIVITIES

  • Inspects or tests components and raw material according to written inspection procedures
  • Inspects electronic or mechanical assemblies, subassemblies, and component parts for compliance with acceptance criteria as defined by specifications, drawings, samples, or illustrations
  • Examines units visually, with microscope or other magnifying device, to determine physical defects according to written inspection procedures.
  • Compares assemblies with drawings, parts lists, illustrations, and / or samples to verify conformance and detect assembly errors
  • Examines the alignment of parts and verifies installation of hardware on assemblies and subassemblies
  • Measures parts for conformance to specified dimensions using measuring instruments or equipment
  • Accepts or rejects materials / product inspected based on conformance to acceptance criteria
  • Records inspection data on appropriate forms, logs, and / or in computer databases
  • Maintains controlled document files and test records in a timely and accurate manner
  • Coordinates calibration of all test equipment and fixtures
  • Monitors critical equipment and instrumentation to ensure proper operation and calibration
  • Identifies and controls nonconforming material and defective products until the material has been quarantined
  • Responsible for identifying, evaluating, recording, and initiating correction or prevention of quality related problems
  • Responsible for identifying and controlling nonconforming material and defective products by segregation or product identification
  • Performs other duties as may be required by management

ADDITIONAL ACTIVITIES

  • Authorized to accept or reject materials / product based upon conformance to acceptance criteria
  • Authorized to segregate and quarantine nonconforming materials / product
  • Authorized to identify and report non-conformances in materials, components, products, processes, equipment, facilities, and other parts of the quality system.
  • Authorized to initiate corrective action.
  • Authorized to identify and initiate corrective action of non-conformances in documentation, design, equipment, facilities, processes, including those activities covered by the Quality System.
  • Authorized to identify non-conformances in documentation, design, equipment, facilities, processes
  • MINIMUM REQUIREMENTS AND QUALIFICATIONS

  • High school graduate or equivalent
  • Exposure to ISO / FDA regulations, Quality Inspection Techniques and Workmanship Standards
  • Proficiency in MS Office
  • DESIRED SKILLS AND QUALIFICATIONS

    Metrology skills, optical comparator use, metric ability, inspection and instrumentation experience, visual measuring equipment i.e. Keyence, Micro-vue.

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    Quality Control Inspector • Webster, TX, US

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