Insulet Corporation

  • Business Analyst, QA Software Systems

    Job Locations US-MA-Billerica | US-MA-Billerica
    Posted Date 5 months ago(5 months ago)
    Category
    Quality Assurance / Quality Engineering
  • Position Summary

    The Business Analyst will work under the guidance of the Sr. Manager, QA Document Control to manage the eQMS software systems to ensure control, security and integrity.  This person is responsible for coordinating and supporting all phases of eQMS system implementation and on-going maintenance.

     

    Responsibilities

     Coordinate required activities related to the development and maintenance of Change Control and Quality workflows in the eQMS software systems, which include but not limited to the following:

    • Process Flow mapping
    • Roles and Privilege mapping
    • Lists of Values
    • Validation, Protocols & Reports
    • Imports of Items, Records, BOMs and File Loads.
    • System upgrades
    • Works with process owners to develop and maintain workflows.
    • Responsible for the maintenance of interface between PLM and ERP.
    • Configure and maintain lists of values across all eQMS software systems including but not limited to Arena Cloud PLM, 123 Compliance, MasterControl and Taleo.
    • Configure and maintain Dashboards
    • Configure and maintain Global Searches
    • Coordinates cloud system upgrade validations.
    • Coordinates on-prem system upgrade validations.
    • Authors and revises QMS SOPs as required.
    • Acts as a liaison between the QA department and IT for all QA Software system needs
    • Coordinates system changes through the IT governance change control process.
    • Performs other duties as required.

     

    Education and Experience

     

    Minimum Requirements:

    • High School Diploma with 3-5 years relevant experience
    • 1-3 years working knowledge in a PLM system.

     Preferred Skills and Competencies:       

    • Associate’s degree with 5+ years relevant experience
    • 3-5 years working knowledge in a PLM system.
    • 1-3 years working knowledge of PLM implementations, upgrades, subsystem development.
    • Demonstrated knowledge of Microsoft Office.
    • Working knowledge of documentation functions of a medical device company
    • Working knowledge of electronic document structure, linkage and best practices
    • Familiarity with ERP (e.g. MFG/Pro, MS Dynamics AX) is a plus, but is not required.
    • Familiarity with LMS (e.g. Taleo, Oracle Learn, Cornerstone) is a plus, but is not required.

     Physical Requirements (if applicable):        

    • N/A

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