C. R. Bard, Inc.

  • Field Assurance Specialist

    Posted Date 3 weeks ago(10/24/2018 7:22 PM)
    Job ID
    Career Level
    entry level
    Bard Peripheral Vascular
  • Overview

    The Field Assurance Specialist (FA) is responsible for managing the complaint handling and reporting processes for devices that have been approved for distribution.

    Summary of Position with General Responsibilities

    The Field Assurance Specialist (FA) initiates domestic and/or OUS complaints, gathers event information, determines reportability per FDA regulations, submits regulatory reports, and provides feedback to the customer, if appropriate. The FA Specialist also provides complaint detail to management, project teams and engineering, as requested.

    Essential Job Functions

    • Document the complaints received by internal customers (i.e. Bard Sales Reps, CS&S personnel, etc.) and external customers (i.e. physicians, patients, etc.).
    • Communicate with internal and external customers to gather additional patient, product, and procedural details related to the complaint record.
    • Evaluate the alleged deficiency to determine if the event meets the definition of a complaint per 21 CFR 820.3.
    • Enter event into the electronic complaint handling database within the allotted timeframe.
    • Assess event for reportability in accordance with FDA regulations (21 CFR 803).
    • Submit medical device reports (MDRs) and/or competent authority reports to the identified regulatory agency.
    • Complete all complaint records in a timely and accurate manner.
    • Assure timely complaint closure, meeting both internal and external requirements and metrics, by tracking and monitoring complaint records and samples from the customer through complaint record closure.
    • Acknowledge receipt of complaint and generate closure letters, as appropriate.
    • Complete QA/FA and FA approvals of the investigation records.
    • Responsible for the secure and accurate maintenance of shared spreadsheets.
    • Monitor product complaints for potential trends.
    • Work in partnership with Engineering to obtain pertinent details that will assist in the investigation and identification of potential root cause of the device malfunction.

    Basic Qualifications

    • Advanced computer skills including database management, spreadsheet, and word processing
    • Knowledge of ISO, FDA Quality System Regulations, Good Manufacturing Practices (GMP)
    • Must have attention to detail and ability to prioritize workload
    • Must read, write, and understand English
    • Must have good organizational and problem solving skills
    • Must be experienced in handling detailed, confidential information/data
    • Skilled in communicating clearly and concisely, both oral and written
    • •Skilled in the understanding of business English usage, spelling, grammar and punctuation.

    Education and/or Experience

    Bachelor’s degree in technical field and 0-1 years experience in healthcare/medical device manufacturing environment.

    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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