Endologix, Inc

  • Field Assurance Medical Records Specialist

    Job ID
    2018-1869
    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 timely completion of assigned activities related to regulatory compliance support activities worldwide. This position is responsible for the ongoing administration, and continuous improvement of record retrieval processed to ensure compliance with US, European, Canadian, and international regulatory compliance and complaint handling/device reporting requirements. In addition, this position is responsible for performing a variety of Field Assurance administrative functions.

    Responsibilities

    • Responsible for the timely completion of medical records and/or imaging request retrieval as required to complete the investigation of complaint files.
    • Responsible for monitoring responses on requests and moving records forward per procedures to assist in the completion of complaint investigations.
    • Responsible for ensuring requests are completed in a timely manner to allow for completion of the rest of the complaint investigation process in a timely manner.
    • Maintains an up‑to‑date knowledge of the company products, policies, and procedures.
    • Assists in the development and/or revision of Quality System documentation and procedures.
    • May assist during FDA inspections, Notified Body audits, customer audits, and other third party audits.
    • As needed, participate in the training and development of other employees.

     

    Qualifications

    Minimum Education:
    • High school diploma with 6+ years or Associate’s degree with 4+ years or Bachelors’ degree with 2+ years of experience in quality

    Minimum Experience:

    • A minimum of 1 year of experience in record retrieval in the Medical Device industry.
    • Minimum of 3 years in FDA regulated industry
    • ASQ or other industry certification desired; 
    • Experience with electronic medical record systems highly desirable;
    • Attention to detail and ability to track requests made required;
    • Excellent oral and written communication skills;
    • Demonstrated professional/proper phone etiquette;
    • Highly organized and attention to detail. Must be accurate in handling detailed information/data;
    • Ability to work independently and as part of an integrated team;
    • Must be able to take direction;
    • Highly resourceful;
    • Speed and accuracy required;
    • Provide positive example and actively promote compliance to procedures and standards;
    • Maintain a professional working relationship with internal and external customers;
    • Working knowledge of GMP/QSR, ISO, Medical Device Directive, and other applicable regulations is expected\
    • Working knowledge of desktop computer, office software, and e-mail is required. Knowledge of TrackWise and DICOM software is preferred.
    • Ability to handle multiple tasks simultaneously and ability to manage project timelines.

     

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

    ·         Good understanding of Good Manufacturing Practices (e.g FDA QSR, ISO 13485 etc.)

     

    CORE COMPETENCIES:

     

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

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

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

    4.     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.

    5.     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.

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

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

    8.     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.

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

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

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

    12.   

    Equipment Use & Abilities Required:

     

     

    1.     Equipment Use:  Copy machines, fax machines, calculators and personal computers and computer terminals. Experienced in Microsoft Word, Excel, PowerPoint and Outlook.  Working knowledge of MS Access and MasterControl desired.

    2.     Computer Skills:  Software proficiency in Microsoft Office Suite.

    3.     Reasoning Ability:   Self-starter, detail oriented and highly organized with flexibility to handle multiple tasks and meet timelines with a focus on compliance to both internal and external requirements. Exercises good judgment skills within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Normally receives no instructions on routine work, general instructions on new assignments

     

    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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