C. R. Bard, Inc.

  • Field Assurance Specialist

    Posted Date 2 weeks ago(5/9/2018 10:40 AM)
    Industry / Category
    Field Assurance Specialist/Quality
    Job ID
    2018-11523
    Career Level
    experienced
    Division
    Bard Medical
    Relocation
    No
    Location
    US-GA-Covington
  • Overview

    Bard has joined BD, together advancing the world of health.  BD Urology & Critical Care, formerly Bard Medical, is looking to fill a Field Assurance Specialist  position at our Covington, GA division headquarters. 

     

    Summary of Position with General Responsibilities

    The Field Assurance Specialist will coordinate the review, investigation, and corrective actions associated with product complaints with the responsible manufacturing facilities in accordance with Corporate and Divisional policies and procedures, Quality System Regulations, and other regulatory requirements. Provides assistance in all areas of complaint handling to ensure that the duties of the department are performed in an accurate and timely manner.

    Essential Job Functions

    • Experience with Trackwise or electronic complaint handling required.
    • Minimum four years of experience with FDA regulated industry including two years in medical complaint handling and MDR/adverse event reporting

    Basic Qualifications

    • Perform complaint and quality investigations related to manufacturing, design or clinical use issues.
    • Review and approve investigations performed by the manufacturing site or OEM supplier.
    • Ensure consistency and attention to detail in performing and documenting complaint investigations.
    • Ensures that the manufacturing sources are notified of all complaints received on products they manufactured and that complaint samples, when received, are forwarded to the manufacturing sources in a timely manner.
    • For investigations, ensure consistency and attention to detail in performing and documenting complaint investigations.
    • Perform final review for closure of complaint files to ensure accuracy, completeness, and attention to detail.
    • Evaluates complaints for determining MDR/Vigilance events and document rationale for not filing MDRs.
    • Determine whether a product malfunction or serious injury reports needs to be filed with the FDA.
    • Determine whether a 30 day or 5 day MDR report is required.
    • Maintain the records of all MDRs and document rationale for not filing MDRs.
    • Create MDRs for review by the Clinical Risk Specialist.
    • Create inquiry reports to the hospitals on reported complaints.
    • Receive complaints and follow-up to collect relevant information from the user.
    • Follow-up with customers and sales representatives to obtain additional information when necessary and to request return of overdue complaint samples.
    • Matches any returned samples with their corresponding complaint files and performs preliminary evaluations on returned samples to verify they are correct per the documented file.

    Education and/or Experience

    • BS/BA degree required.
    • Experience with Trackwise or electronic complaint handling required.
    • Minimum four years of experience with FDA regulated industry including two years in medical complaint handling and MDR/adverse event reporting

    Physical Demands

    While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is frequently required to use hands to finger, handle or feel. The employee is occasionally required to stand and reach with hands and arms and lifts and/or moves up to ten pounds. Employee is required to meet with other personnel in other areas of building. Specific vision abilities required by this job include close vision.

    Work Environment

    This position works in a normal office environment. The noise level in the work environment is quiet to moderate. This position also has exposure to laboratory environment, which may require handling of all types of chemicals including those that present health, flammability, and reactivity hazards. Must be trained in blood-borne pathogens and handling bio-hazardous materials.  #LI-CW1

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