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  • Validation Engineer - Caguas - QRC Group, LLC

    QRC Group, LLC
    QRC Group, LLC Caguas

    hace 2 meses

    $60,000 - $120,000 (USD) al año *
    Descripción
    Validation Engineers to support the internal development and validation of a multi-dose preservative-free (MDPF) nozzle subsystem and any other miscellaneous project related deliverables as they arise.

    Location: SouthEast, United States (Travel Required)
    Scope Includes:
    • Validation of new molding and assembly units
    • Qualification of ISO7 clean rooms
    • Integration of metrology instruments and handling systems
    • Execution of IQ/OQ/PQ protocols, FAT/SAT, and traceability documentation
    • Collaboration on a comprehensive Validation Master Plan
    Location: SouthEast, United States (Travel Required)

    Requirements

    • Bachelor's in Engineering (Mechanical, Biomedical, Chemical, or Industrial)
    • Location: SouthEast, United States (Travel Required)

    Technical Skills

    • IQ/OQ/PQ protocol development and execution
    • FAT/SAT testing and documentation
    • Validation Master Plan (VMP) creation
    • MES/SCADA system qualification
    • Injection molding and automated assembly validation
    • Metrology equipment calibration and Gage R&R
    • Traceability Matrix development
    • Experience with KNEAT software (highly desirable)

    Regulatory Knowledge

    • FDA 21 CFR Part 820
    • EU MDR 2017/745
    • ISO 13485 & ISO 14971
    • GMP compliance

    Certifications

    • ISO 13485 Quality Management
    • ISO 14971 Risk Management
    • GMP Training
    • Six Sigma (Green or Black Belt)

    Soft Skills

    • Strong documentation and report writing
    • Cross-functional collaboration
    • Ability to train personnel
    • Analytical thinking and problem-solving
    Location: SouthEast, United States (Travel Required)

    * Este rango salarial es una estimación realizada por beBee
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