Endologix, Inc

  • Sr. Quality Complaints Specialist

    Job ID
    2018-1826
    Location
    US-CA-Irvine
    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 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

    • Primary contact for all customer complaint handling and reporting activities related to Endologix products.
    • This individual is responsible several aspects of handling product complaints such as:
    • 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. 
    • Make complex reporting decisions regarding FDA MedWatch requirements as well as European Vigilance reporting requirements and other countries that Endologix product is sold in. Using good judgment skills to determine if serious injuries or malfunctions have occurred and if so, whether or not they are reportable events.
    • Determine timelines with Quality Engineers 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.
    • Performs collective trending analyses of product complaints and implant reports for trends and identification of potential corrective or preventive actions.
    • Prepares complex reports requiring research into sales data to determine occurrence rates of complaints.
      Researches and interprets risk analysis information to determine the severity of the complaint and performs complex analysis of similar events which requires a high degree of discretion and judgment.  These reports are used to respond to international requests from government authorities where Endologix sells product.   
    • Prepares reports for periodic management reviews.
    • Ensures applicable domestic and international regulations related to Risk Management and Medical Device Reporting are met.
    • Perform other duties as assigned by supervisor.

     

    Qualifications

    Minimum Education:

     

    Bachelor’s degree in a scientific discipline or equivalent.

     

    Minimum Experience:

     

    years of related work experience, including:

    ·         Minimum of 5 years of experience in complaint handling in the Medical Device industry. 

    ·         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.

     

     

    Specific Skills, Knowledge & Behaviors

     

    (To perform the job successfully, an individual should demonstrate the following competencies):

     

    Core Competencies:

    ·         Customer Focus: Solicit and apply feedback from internal and external customers; Understand customers’ current and future expectations; Respond promptly to customer needs.

    ·         Innovation: Develop and champion unique ideas and solutions; Find new ways to use technology more effectively; Promote continuous learning.

    ·         Interdependent Partnering: Contribute to a productive and cooperative atmosphere; Show commitment to team objectives; Contribute own fair share of effort.

    ·         Master Complexity: Competently handle day-to-day work challenges; Thrive in uncertain circumstances; Adapt to changes in the work environment; Manage multiple tasks and competing demands; Change approach or method to best fit the situation.

    ·         Organizational & People Development: Function as both team player and leader; Provide informal feedback; Challenge the status quo; Strive for continuous professional development; Recognize the contributions of others; Set and achieve challenging goals.

    ·         Spoken Communication: Speak clearly and concisely; Listen carefully and seek clarification; Deliver effective presentations.

    ·         Written Communication: Write clearly and informatively; Create documents that are complete and accurate.

    ·         Commitment: Strive to attain quality results on time; Convey a sense of urgency and drive issues to closure; Earn a reputation for reliability and dependability.

    ·         Decisions: Make timely and sound decisions; Take risks and manage them intelligently.

    ·         Problem Solving: Proactively seek solutions; Gather and analyze information systematically; Develop alternative solutions; Think analytically and act decisively.

    ·         Diversity: Respond with sensitivity to people of diverse perspectives, ideas, backgrounds, lifestyles and ages; Foster open communication and respect for the individual.

     

    Equipment Use & Abilities Required:

     

    ·         Equipment Use:  Copy machines, fax machines, calculators and personal computers and computer terminals.

    ·         Computer Skills:  Software proficiency in Microsoft Office Suite.

    ·         Language Skills:  Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, legal documents or governmental regulations.  Ability to write reports, business correspondence, and procedure manuals.  Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. 

    ·         Mathematical Skills: Ability to work with mathematical concepts such as probability and statistical inference.  Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. 

    ·         Reasoning Ability: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form 

     

    WORK ENVIRONMENT & PHYSICAL DEMANDS OF THE JOB:

     

    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to stand; walk, and sit for extended periods of time.

     

    Endologix, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected 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

     

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