USA - Sr. Quality Engineer - Cleveland, United States - eTeam

    eTeam
    eTeam Cleveland, United States

    1 month ago

    eTeam background
    Description

    Job Title:
    Supplier Quality EngineerLocation: Cleveland, MS- 100% OnsiteDuration: 6+ Months

    Pay Rate:
    $55.00/hr on W2 to $58.

    00/hr on W2Job Description:

    • Follow up on supplier audits to demonstrate supplier controls required by FDA CFR 820, ISO 13485 and ISO 9000.
    • Works with suppliers to find solutions to identified problems.
    • Create written reports and communicate the results clearly and effectively to the auditee and Client's management.
    • Manage and insure timely implementation of supplier Corrective Action Reports (SCARs).
    • Provide engineering support for nonconforming material (NMR) and Return Material Authorization (RMA) issues.
    • Remediate Supplier files to support current and business development activity related to acquisition of new businesses.
    • Remediate SNC Process,
    • Verify supplier files are maintained and documented appropriately.
    • Provide supplier metrics to management.
    • Lead the supplier approval process by assessing manufacturing, Quality Systems capabilities and risks.
    • Develop Improvement plans for Critical to quality suppliers.
    • Manages personnel to maintain and reduce the Incoming Inspection cycle time.
    • Establishes problem solving strategies and work with Manufacturing and Quality Engineers to reduce MRB inventory
    • .Perform component characteristic analysis to determine inspection status changes.
    What you'll bring

    • Knowledge of FDA CFR 820, ISO 13485 and ISO 9000 requirements, strongly desired ISO 13485 Lead Auditor certification.
    • B.S Degree in Engineering required.
    • 5+ year qualifying experience, including previous experience with quality auditing, specifically supplier audits. Excellent documentation, communication and excellent problem-solving skills desirable.
    • Oral and written communications in English