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QA Specialist

Micro Tech Staffing Group

  • Youngsville, NC
  • Today

    Highlights

    Perform receiving, in-process, and/or final inspections of purchased and customer-owned parts for disposable medical devices and electro-mechanical assemblies. Communicate discrepancies or concerns with suppliers and initiate and follow up on Supplier Corrective Action Preventive Action (SCAPA) requests.

    Numbers & Facts

    LocationYoungsville, NC

    Description

    • Perform receiving, in-process, and/or final inspections of purchased and customer-owned parts for disposable medical devices and electro-mechanical assemblies.
    • Perform activities related to the documentation, control, disposition, and root cause analysis of nonconforming material.
    • Review Device History Records and other documentation for compliance with established procedures and Good Documentation Practices.
    • Provide assistance, guidance, and oversight to Manufacturing during rework activities.
    • Accurately document inspection and testing results.
    • Maintain controlled document files and test records in a timely and accurate manner.
    • Maintain a thorough understanding of individual component specifications, blueprints, and sampling plans.
    • Write accurate and detailed nonconforming material reports.
    • Communicate discrepancies or concerns with suppliers and initiate and follow up on Supplier Corrective Action Preventive Action (SCAPA) requests.
    • Conduct and document roving process, equipment setup, and system audits using written procedures as audit standards.
    • Monitor critical equipment and instrumentation to ensure proper operation and calibration.
    • Provide support to Quality Engineers with testing and data collection during validation activities.
    • Provide support to the QA Supervisor in maintaining the calibration program and collecting bioburden samples and data.

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