Endologix, Inc

  • Documentation Coordinator

    Job ID
    2018-1919
    Location
    US-CA-Santa Rosa
    Category
    Quality
  • Overview

    Endologix develops and manufactures the latest innovations in endovascular aneurysm repair and sealing. We are a fast-moving, high energy organization. Employees are offered development opportunities and new responsibilities that might have taken them significantly more time in other organizations. Our commitment is to promise the development and refinement of skills while providing competitive compensation and benefits.

     

    This position works cross-functionally to support efforts to define, setup and maintain an automated Quality training system for Endologix.  Maintains records management for Quality Systems and is responsible for backup support for Document Control.

    Responsibilities

    • Tracks training compliance and reports status of company-wide training compliance.
    • Coordinates training compliance for satellite employees.
    • Processes protocols and reports, scans and uploads document to MasterControl.
    • Supports user requests for documentation and updates satellite areas within facility.
    • Orders external standards, maintains tracking system and coordinates review with users.
    • Maintains records in the document control storage room in a state of audit readiness.
    • Responsible for providing backup support for coordinating document change orders (DCO), coordinates review and approval.
    • Responsible for the retention of Risk Management documents.
    • Performs filing and scanning of quality system documentation.
    • Other duties as assigned by the supervisor.

    Qualifications

    • Knowledge of ISO and GMP regulations desired.
    • Knowledge of documentation control requirements for medical device manufacturing to meet FDA and ISO 13485 regulations desired.
    • Must be detail-oriented and posses strong organizational and time management skills with the ability to prioritize and manage completion of multiple tasks/projects with company personnel.
    • Strong interpersonal skills, with the ability to communicate effectively with all levels of staff including non-technical and technical personnel.
    • Must be quality oriented and willing to promote quality standards.

    Education:

    • High school diploma required, Bachelors Degree preferred.

    Experience:

    • Experience in a pharmaceutical or medical device manufacturing environment desired.
    • Experience with electronic documentation & training system a plus.

    Endologix, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity, gender expression, genetic information, marital status, veteran status or any other characteristic protected by applicable federal, state, or local law.

                                                

    If you are a qualified individual with a disability or a disabled veteran, you have the right to request an accommodation if you are unable or limited in your ability to use or access our career center as a result of your disability. To request an accommodation, contact a Human Resources Representative at Endologix Global Headquarters at 949-595-7200 or Endologix Santa Rosa Facility at 707-543-8800

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed