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Eden Prairie

    Quality Systems Engineer II - Eden Prairie, United States - ACIST Medical Systems

    ACIST Medical Systems
    ACIST Medical Systems Eden Prairie, United States

    1 day ago

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    Description

    Position Summary:
    This position supports the validation, implementation, and maintenance of Bracco Medical Technologies internal Quality System software.

    This role will be responsible for owning and maintaining processes to appropriately control and validate Quality System software applications, oversee and manage validation activities and documentation for all QMS applications.

    As a system analyst, this role will analyze, develop, and maintain certain QMS applications and implement configuration changes and improvements.


    Primary Duties & Responsibilities:
    Quality System Software Validation


    Implement and maintain processes and procedures to ensure that all QMS software is constructed and validated according to the appropriate regulations and guidelines, including 21 CFR Part 11.


    Manage all aspects of validation for QMS software that is managed internally, including Master Validation Plan, requirements, risk assessment, IQ/OQ/PQ protocols and reports, configuration and traceability documentation, and associated validation project management.

    Scale validation activities according to risks.

    Manage changes to QMS software applications, including use of change control tool, change impact analysis, procedures and associated documentation.

    Provide ACIST Quality support and approvals for implementation and changes to applications that are managed by Bracco corporate (e.g. SAP and TrackWise).

    Maintain an inventory of QMS software applications and validation status, in conjunction with IT and other departments. Review and update at specified intervals lead activities required to maintain compliance.

    Provide guidance, support, and approvals for validation and control of spreadsheets and electronic forms.

    Support the assessment and management of vendors and outsourced services related to QMS software applications and associated validation.

    As subject matter expert for QMS software validation, maintain current knowledge of regulatory environment, standards, guidance and regulations.

    Provide guidance and training to staff regarding software validation.

    QMS Application Analyst

    Analyze, develop, support, and maintain Agile PLM system and other applications/databases as necessary.


    Support the configuration and implementation of additional modules of the Agile PLM system, new QMS applications, and changes to existing applications.


    Work with various business teams to gather requirements, design, develop and document QMS applications/databases in order to support business processes.

    Develop user documentation and provide training to end users of QMS applications.

    Project management of system implementations, modifications and enhancements.

    Seek development activities to enhance technical expertise with Agile PLM and other applications.

    Manage user access requests and approvals for quality system software.

    Other Software Support

    Provide software QA support to development teams for product software.

    Support verification and validation of product and test system software.

    Support software risk assessment and associated documentation and provide guidance on appropriate scaling of validation activities.

    Analyze and support implementation of data integrity best practices.

    Support or lead resolution of software-related corrective action projects (CAPA).

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