Manufacturing Engineer

Katalyst Healthcares & Life Sciences

  • Morgantown, WV
  • 17 days ago

    Highlights

    Support/Initiate Change Order for manufacturing documentation such as but not limited to, manufacturing procedures, shop floor paperwork, and inspection procedures. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

    Numbers & Facts

    LocationMorgantown, WV

    Description

    Roles & Responsibilities:
    • Support in Manufacturing process remediation and readiness activities for new product launch.
    • Support Design Transfer deliverables, including tracking and scheduling.
    • Support/Initiate Change Order for manufacturing documentation such as but not limited to, manufacturing procedures, shop floor paperwork, and inspection procedures.
    • Risk Management updates PFMEA.
    • Part creation in Windchill. BOM and configuration management.
    • Work with cross functional teams as required, especially with R&D, Quality, and Regulatory teams.
    • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
    Requirements:
    • Knowledge of ISO and/or FDA quality system regulations as it pertains to design transfer and process control.
    • Previous medical device experience
    • 5+ years of Medical device Manufacturing experience

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