Endologix, Inc

  • Sr. Field Assurance Specialist

    Job ID
    2018-1982
    Location
    US-CA-Irvine
    Category
    Quality
  • Overview

    This position is responsible for the ongoing administration, supervision and continuous improvement of Quality Systems to ensure compliance with US, European, Canadian, and international regulatory compliance and complaint handling/device reporting requirements. This position also is responsible for the timely completion of assigned activities related to regulatory compliance support activities worldwide.

    Responsibilities

    • Serves as a primary contact for customer experience reporting and complaint handling activities related to Endologix products.
    • Responsible for ownership of product complaints, including:
      • Receiving complex medical procedure information (type of procedure performed, types of devices used, patient condition and any complicating factors, etc.) and asking probing questions to ensure the full picture of what occurred is captured
      • Documenting the events that occurred in such a manner as they are chronological and make sense to a variety of readers
      • Investigating complaint information received such as obtaining medical records and images, coordinating retrieval of returned devices and working with customs if necessary.
      • Developing and writing responses to customers for product complaints. Take complex medical procedure information and determine the course of events related to each complaint and write investigation findings in response to customer inquiries.
    • Ensures timely and accurate reporting regarding FDA MedWatch requirements as well as European Vigilance reporting requirements and other countries that Endologix product is sold in. Determines if serious injuries or malfunctions have occurred and, if so, whether or not they are reportable events.
    • Collaborates with RFA to ensure timely evaluation of product complaints and timely completion of reports with this information to regulatory bodies.
    • Develops good working relationships and collaborates with Sales personnel, Customer Service, Engineering, Manufacturing, Quality Assurance, Clinical Affairs, EU Representative, distributors and physician users in these investigations.
    • Maintains current and complete complaint files.
    • Identifies and contributes to or leads process improvement projects within the Field Assurance processes.
    • Ensures applicable domestic and international regulations related to Risk Management and Medical Device Reporting are met.

    Qualifications

    • Extensive knowledge of medical device regulations.
    • Comprehensive knowledge of quality systems and relationship to business.
    • Ability to facilitate and provide leadership concerning customer complaint investigations.
    • Must demonstrate technical writing ability.
    • Good interpersonal skills including ability to interact with high degree of diplomacy.
    • Ability to work in a fast-paced, technically challenging environment where drive is critical to success.
    • Provide leadership concerning investigation activities and facilitate the timely closure of complaint investigations.
    • Must be self-motivated and self-disciplined and able to prioritize and handle multiple tasks and responsibilities.
    • Effective problem solving techniques and excellent applied thinking skills.
    • Strong communication and organization skills required.
    • Expertise in Microsoft Office applications and charting programs.

    Minimum Education:

    • Bachelor’s degree in a scientific discipline or equivalent

    Minimum Experience:

    • Minimum of 3-5 years of experience in complaint handling in the Medical Device industry.
    • Knowledge of medical device regulations.
    • Knowledge of quality systems and relationship to business.
    • Ability to facilitate customer complaint investigations.
    • Must demonstrate technical writing ability.
    • Good interpersonal skills including ability to interact with high degree of diplomacy.
    • Ability to work in a fast-paced, technically challenging environment where drive is critical to success.
    • Facilitate the timely closure of complaint investigations.
    • Must be self-motivated and self-disciplined and able to prioritize and handle multiple tasks and responsibilities.
    • Effective problem solving techniques and excellent applied thinking skills.
    • Strong communication and organization skills required.
    • Experience with Microsoft Office applications.
    • Experiences with TrackWise is preferred.

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