Endologix, Inc

  • Supervisor, QA/QC

    Job ID
    2018-1859
    Location
    US-CA-Santa Rosa
    Category
    Quality
  • Overview

    Manage daily activities for Quality Assurance and Quality Control teams, which include performing QA review of manufacturing records and inspections, checks, and tests of incoming materials, components used in the manufacture of medical devices and finished goods. Ensures product meets specified requirements and work performed complies with cGMP/GDP policies and internal procedures. Responsible for periodic environmental monitoring of clean room areas. The QA/QC supervisor will ensure adequate resources are available to meet manufacturing demand and meet cost and timeliness quality metrics of the QA/QC departments. Responsible for reporting area metrics and continuous improvement of procedures and practices.

    Responsibilities

    • Supervise Quality Assurance team. Ensure daily review and approval of manufacturing records and inspections are completed and deadlines are achieved.
    • Supervise Receiving Inspection and Assembly Inspection team. Assign priorities and resources. Provide support to manufacturing to ensure daily workloads and deadlines are achieved.
    • Hire and train QA/QC employees. Ensure company policies and departmental procedures are followed.
    • Work with Production, Manufacturing Engineering and Quality Assurance Management to provide feedback to Production team regarding accuracy of assembly procedures and recommend opportunities for improvement.
    • Participate in creation and/or revision of inspection procedures and protocols.
    • Assist in conducting and documenting process and system audits using specific regulations and company procedures as audit standards.
    • Assist in maintenance of Quality Systems including Internal Audits, area metric reporting, and Non-Conforming Material Reports.
    • Coordinate calibration of all applicable equipment, tools, and fixtures.  
    • Support environmental monitoring of clean room areas.
    • Lead receiving inspection test method validation activities.
    • Identifies hazards and mitigates risks related to Endologix products, processes, and Quality System. Reports risks to executive management.
    • Evaluate and review individual performance on a regular basis.
    • Ensure a safe working environment and enforce safety rules and policies.
    • Evaluate issues and make recommendations for corrective action and improvement to department manager.
    • Supervise and monitor attendance for QA/QC teams and maintain timekeeping activities.

    Qualifications

    • BS degree in engineering or sciences or equivalent experience in Quality Operations
    • Minimum 3 years of supervisory experience is required
    • Minimum 5 years of experience in the medical device industry preferred

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