ZOLL Circulation, Inc.

  • Post Market Surveillance Analyst

    Job Locations US-CA-San Jose
    Posted Date 1 week ago(5/16/2018 7:38 PM)
    Job ID
    2018-1056
    # of Openings
    1
    Category
    Quality Assurance
  • Overview

    General Summary:

    The Post Market Surveillance Analyst is responsible for performing the domestic and international product surveillance activities for medical devices, manufactured, marketed, distributed and serviced by ZOLL. Primary responsibility for all administrative activities associated with the complaint handling program including, but not limited to, reviewing, managing and closing complaints records in the complaint handling system. The Post Market Surveillance Analyst will prepare failure analysis responses for customers and close complaints. Position may also be responsible for some regulatory reporting.

    Responsibilities

    Essential Functions:

    • Perform the preliminary classification of complaints and elevate complaints that require reporting for additional review.
    • Evaluate documentation for completeness and consistency, and execute additional actions as necessary to close the complaint file.
    • Recognize complaint trends, potential product problems and potential recalls, and initiate immediate remedial action, if appropriate.
    • Identify and elevate new failure modes when encountered.
    • Maintain oversight of the Complaint Handling daily processes to ensure issues are being addressed in a timely and compliant manner.
    • Communicate with Clinicians, Clinical Education, Sales and Marketing teams, and other internal or external customers, to identify details related to complaint information and occurrence.
    • Perform Good Faith Effort for product return and to obtain required information for complaint assessment and evaluation.
    • When necessary, perform investigation of returned devices.
    • Work with engineering groups to ensure testing as required on product investigations is completed.
    • Prepare responses to customer requests for failure analysis as necessary.
    • Proactive individual with ability to communicate and work well with others.

    Qualifications

    Skill Requirements:

    • Be able to identify missing information, evaluate accuracy of the presented information
    • Demonstrates strong attention to detail.
    • Listens and gets clarification; responds well to questions; understands nuances related to complaints, and customer matters.
    • Writes clearly and informatively; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information.
    • Follows policies and procedures; supports organization's goals and values.
    • Adapts to changes in the work environment; manages competing demands; changes approach or method to best fit the situation; able to deal with frequent change, delays, or unexpected events.
    • Follows instructions, responds to management direction; takes responsibility for own actions; keeps commitments; commits to long hours of work when necessary to reach goals; completes tasks on time. Keeps and follows up on commitments.
    • Demonstrates persistence and overcomes obstacles
    • Prioritizes and plans work activities; uses time efficiently; develops realistic action plans.
    • Demonstrates accuracy and thoroughness; applies feedback to improve performance; monitors own work to ensure quality.

       

     

      

    Education/Training/Experience Requirements:

    • BS in Science or Engineering. Equivalent QA experience considered.
    • Experience using Microsoft Word, Excel.

     

     

    Language Ability:

    Ability to read, analyze and interpret complex quality documents.

     

    Math Ability:

    Ability to apply and understand basic arithmetic operations.

     

    Reasoning Ability:

    Ability to identify potential problems and discuss findings with Quality Management.

     

    Computer Skills:

    Working knowledge of desktop computer and software programs.

     

    Certificates and Licenses:

    No certifications needed.

     

    Work Environment:

    The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

     

    The noise level in the work environment is usually moderate.

     

    Physical Demands:

    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 sit and talk or hear. The employee is also required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. Specific vision abilities required by this job include close vision, distance vision and ability to adjust focus.

     

    Preferred Experience:

    • Complaints handling, Quality Systems in a medical device regulated environment.
    • Previous experience in quality functions for the medical devices industry is preferred.

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