Insulet Corporation

  • Post Market Surveillance Specialist

    Job Locations US-MA-Billerica | US-MA-Billerica
    Posted Date 2 months ago(2 months ago)
    Category
    Quality Assurance / Quality Engineering
  • Position Summary

    This position is integral to supporting the department through data analysis, reporting, trending, documentation review, coordination of complaint and lot qualification data, device history reviews, and review and closure of certain categories of complaints.  It requires organization and attention to detail while working with other functions within the organization to ensure compliance and accomplishment of tasks.

    Responsibilities

    • Perform data entry and prepare reports / graphs related to special projects, complaints and lot qualification.
    • Maintain accurate documentation and files related to special projects, complaints and lot qualification.
    • Review and analyze lot documentation (DHR’s) to determine if there are any anomalies that may have related to reported product failures.
    • Support database development and reporting capabilities related to the complaint / reliability department needs.
    • Process feedback letters and communicate to product support managers for various reporting sites.
    • Perform basic product review and failure analysis.
    • Assist in gathering information and data during FDA, ISO or other third party or internal audits.
    • Support investigation and review of potential adverse events.
    • Assist with Post market surveillance reporting (MDRs, MDVs, MDPRs, etc.).
    • Performs other duties as required.

    Education and Experience

    Minimum Requirements:

    • Associate's Degree

     Preferred Skills and Competencies:       

    • Minimum of 3-5 years’ experience with data management, record keeping, and trouble shooting in the Medical Device field, or other transferable experience related to organization, technical aptitude and data management.
    • Effective verbal and technical writing skills. Ability to communicate at multiple levels 
    • of an organization.
    • Ability to organize and judge priorities.
    • Excels at generating and maintaining organized and accurate records.
    • PC skill, word processing, spreadsheet, database.
    • Able to work effectively in a high-stress, high-energy environment.
    • Able to make decisions quickly based on vague or imperfect information and evaluate the need to obtain clarification and direction when necessary.

     Physical Requirements (if applicable):        

    • This position is a desk job and require sitting for extended periods of time.

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