C. R. Bard, Inc.

  • Field Assurance Manager

    Posted Date 4 weeks ago(7/25/2018 11:01 AM)
    Industry / Category
    Field Assurance Manager/Quality
    Job ID
    2018-11933
    Career Level
    management
    Division
    Bard Medical
    Relocation
    Yes
    Location
    US-GA-Covington
  • Overview

    This position manages the Field Assurance Department including capital equipment and the investigation lab.

    Summary of Position with General Responsibilities

    This position manages the Field Assurance Department from a global perspective and provides a high degree of confidence that all product complaints received on products manufactured and/or marketed by Bard Medical Division (BMD) and any of its business groups are documented and maintained in compliance to applicable Quality Systems regulations, ISO requirements, FDA regulations, and Corporate, Business Unit, and International regulations, policies and procedures.

    Essential Job Functions

    Primary Responsibilities

    • Establish the systems and processes for receiving and handling complaints.
    • Establish the systems and processes, including the assessment tools for determining and reporting eMDRs.
    • Establish a process by which complaints in the post market surveillance studies and clinical studies are entered in the complaint system.
    • Coordinates the review, investigation, and corrective actions of product complaints with manufacturing source Quality Assurance personnel to ensure consistency and attention to detail in performing and documenting complaint evaluations.
    • Interacts with other manufacturers to establish complaint handling, adverse event reporting, and distributor reporting responsibilities.
    • Interprets corporate policies and regulations as they relate to Field Assurance, and prepares and implements Business Unit procedures for conformance, when necessary.
    • Prepares departmental budget and operates within the budget.
    • Ensures the accuracy and efficiency of complaint documentation from the initial receipt of a product complaint and opening of a complaint file to the closure of the file.
    • Manage complaint turnaround times and corrective action follow-up.
    • Ensures the selection, orientation, development, and retention of a sufficient number of qualified staff to carry out the responsibilities of the department.
    • Serves as a contact for responding to FDA inquiries. Investigates, documents, and files adverse event reports (both domestic and international) for products marketed by BMD.
    • Serves as the contact for responding to MHRA inquiries. Investigates, documents, and files adverse event reports (both domestic and international) for products marketed by BMD.
    • Ensures that all complaints on products marketed by BMD and any of its associated business groups are received, documented, analyzed, and trended in accordance to Corporate and Business Unit policies and procedures, and applicable regulations.
    • Manage the Legal team, the Disposables team, the Capital Equipment team and the Laboratory Investigation team to ensure complaints are managed from intake to closure including reporting requirements, investigation and closure.
    • Ensures trending reports are generated and presented to upper management as required.
    • Coordinate worldwide exchange of complaint information.
    • Facilitate the communication of complaint trends to business franchise teams to ensure that compliance and business requirements are met.
    • Monitor user-related complaint trends. Coordinate customer in-servicing and follow-up with Sales Force and Clinical Educators.
    • Based on customer experience, provide input as needed into the development of sales force training materials.
    • Interacts with Corporate Legal in responding to litigation requests, reimbursement requests, and evaluation results requests for BMD.
    • When required, respond to interrogatories, collection of documents and participate in depositions.

    Basic Qualifications

    • Proficient in the use of a personal computer with intermediate level of keyboarding skills.

    • Strong interpersonal skills required in the areas of verbal and written communications, customer focus, service to internal customers, telephone manner, professionalism, coaching, influencing, and team building.

    • Strong listening and assessment skills.

    • Strong questioning & problem-solving skills.

    • Detail oriented, committed to accuracy, efficiency, and consistency.

    • Good proofreading skills and memory retention.

    • Must be self-motivated and self-disciplined and able to prioritize and handle multiple tasks and responsibilities.

    • Must be able to manage people and control stressful situations.

    • Must be able to maintain a calm and positive approach to negative issues and resolve day-to-day problems associated with managing the personnel and duties of the Field Assurance Department.

    • Must be able to maintain legible, accurate records.

    • Good written and verbal communication skills.

    Education and/or Experience

    • Four-year degree in science or technical field.
    • Minimum eight (8) years of experience with FDA regulated industry including five years in complaint handling, MDR/adverse event reporting, and complaint investigations.
    • Minimum five (5) plus years managerial experience.

     

    Physical Demands

    This position requires sitting, standing, walking, computer work, and lifting up to 20 pounds.

     

    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.

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