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    Senior Quality Assurance Engineer - Miami, United States - Compunnel, Inc.

    Compunnel, Inc.
    Compunnel, Inc. Miami, United States

    3 weeks ago

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    Description

    Job Description

    Job Description
    Description
    RESPONSIBILITIES:Provide strategic direction for design change teams in terms of quality functions including design quality, manufacturing quality, process validation, supplier quality, post-market quality and risk management.

    Ensure proactive compliance to all applicable internal, domestic, and international regulations including US 21 CFR 820 (QSR), ISO 19471:2019 and ISO 13485:2016.Ensure compliant and complete product documentation, inclusive of DHFs, with particular focus on design controls, risk management and document controls.

    Lead extended Quality teams for design change projects.

    Review and approve design and development documentation including Design Development plans, Design Change plans, User Needs, Design Input and Design Output documents, Design Verification Protocols and Reports, Design Validation Protocols and Reports, and System Risk Assessment documentation.

    May review and approve engineering drawings, specifications, procedures, engineering changes, and manufacturing work instructions, etc.
    Assures that products subjected to design changes are successfully transferred into the supply chain including manufacturing and service environments.
    Participates in Design Reviews and develop, approve, and review associated documentation.
    Responsible for Design History File (DHF) completeness and maintenance.
    Utilize problem solving techniques ad take a broad perspective to identify innovative solutions.
    Interact frequently with other functional areas and operating entities which requires specialized depth and/or breadth of expertise.

    Additional client information:

    Company DescriptionCompunnel Inc., established in 1994; is a leading provider of Staffing, IT/Software, e-Learning/Training, Business Intelligence, and Cloud Solutions.

    A leader in contingent and permanent workforce solutions, we also provide temp-to-hire staffing, project-based/SOW staffing, and payroll services to our esteemed clientele which includes Fortune 500 companies of diverse industry segments.

    Ranked as one of the largest staffing firms in the US which is our primary service market; we also have a significant presence in Europe and Asia.

    As a national service provider in the US, we are serving our customers all major states and regions; thereby generating numerous job opportunities for prospective employees in their preferred locations of choice.

    We have witnessed multi-fold YOY growth, and continuously adding a large pool of talented resources to our employee base every year.

    Our extensive experience in hiring professionals of multiple in-demand skill sets (IT, Engineering, Healthcare, Admin-Clerical, Finance, Professional, Light Industrial, etc.) further makes Compunnel a wider and preferred platform for people to pursue their careers in the US.

    We welcome people from all walks of life and cultures, and we support workforce diversity by providing equal employment opportunities to people without any discrimination based on race, color, gender, religion, national/ethnic region, disability, or any other basis.

    Company Description

    Compunnel Inc., established in 1994; is a leading provider of Staffing, IT/Software, e-Learning/Training, Business Intelligence, and Cloud Solutions.

    A leader in contingent and permanent workforce solutions, we also provide temp-to-hire staffing, project-based/SOW staffing, and payroll services to our esteemed clientele which includes Fortune 500 companies of diverse industry segments.

    Ranked as one of the largest staffing firms in the US which is our primary service market; we also have a significant presence in Europe and Asia.

    As a national service provider in the US, we are serving our customers all major states and regions; thereby generating numerous job opportunities for prospective employees in their preferred locations of choice.

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    We have witnessed multi-fold YOY growth, and continuously adding a large pool of talented resources to our employee base every year.

    Our extensive experience in hiring professionals of multiple in-demand skill sets (IT, Engineering, Healthcare, Admin-Clerical, Finance, Professional, Light Industrial, etc.) further makes Compunnel a wider and preferred platform for people to pursue their careers in the US.

    We welcome people from all walks of life and cultures, and we support workforce diversity by providing equal employment opportunities to people without any discrimination based on race, color, gender, religion, national/ethnic region, disability, or any other basis.

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