C. R. Bard, Inc.

  • Clinical Field Assurance Specialist- Temporary

    Posted Date 2 weeks ago(4/6/2018 11:19 AM)
    Industry / Category
    Medical Device/Quality
    Job ID
    2018-11406
    Career Level
    experienced
    Division
    Bard Peripheral Vascular
    Relocation
    No
    Location
    US-AZ-Tempe
  • Overview

    Becton, Dickinson Interventional (BDI) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 65,000 people across 50 countries around the world. Founded more than 100 years ago, BDI pioneered many devices that are cornerstones of modern healthcare.  BD - PI is the vascular division within BDI and focusses on interventional products for peripheral arterial disease (PAD), end stage renal disease (ESRD), and Cancer.

     

    We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness, respect, and feel valued, acknowledged and rewarded.

     

    Be Your Best at BD-PI – and ultimately, you can have an impact on the lives of people around the world.

    Summary of Position with General Responsibilities

    Provide clinical/medical insight into the complaint handling process at Bard Peripheral Vascular. This is a temporary position expected to last through September.

    Essential Job Functions

    • Responsible for customer complaints to assess, evaluate, and determine MDR reportability per FDA guidelines.
    • Participate in decision making and/or the review process related to global reporting determinations.
    • Participate in creation and maintenance of MDR Reportability Guideline documentation.
    • Responsible for completing medical record and journal article reviews related to product complaints.
    • Assess the clinical severity level and document in the complaint record.
    • Provide clinical and technical assistance and/or training to the Field Assurance personnel.
    • Interface with hospital Risk Management and physicians involving complex adverse events.
    • Interface with internal/external customers with regard to the clinical impact of the product and customer dissatisfaction. Perform customer site visits, as necessary.
    • Draft and/or review customer results letters related to complaints.
    • Support internal, Corporate, and external regulatory audits.

    Basic Qualifications

    Strong organizational and analytical skills.

    Excellent communication skills, both written and oral.

    Ability to interact effectively with internal and external customers

    Additional Desirable Qualifications Skills and Knowledge

    Prior training and knowledge in the review and analysis of x-ray, CT, and other medical imaging related to customer complaints.

    Education and/or Experience

    • RN or other appropriate clinical license or degree required.
    • Minimum one (1) year clinical and/or medical device experience preferred.
    • Knowledge and/or experience with FDA Quality System Regulations and Guideline and related quality standards.
    • Computer proficiency with standard software programs, i.e. Microsoft Office.

    Physical Demands

    While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment.  The employee frequently is required to talk and hear.The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch. 

    Work Environment

    While performing the duties of this job, the employee may be in an open cubicle environment.  Candidate must be able to work in a team-oriented, fast-paced environment. Bard Peripheral Vascular is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

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