Altran - Bordentown

  • QMS Specialist Consultant II

  • Company Overview

    Today’s complex interconnected world demands companies to conceptualize and deliver cutting-edge products and solutions to market faster than ever before. Altran, a global product development partner, collaborates with companies to address the business and technical challenges inherent in developing and supporting complex connected systems.

     

    For over three decades, leading companies and emerging startups in some of the most highly regulated and rapidly evolving industries have relied on Altran to inspire innovation, accelerate time to market, improve predictability, and maximize return on product investment. Altran provides a full complement of technology consulting, software and product development expertise, and engineering services to our client partners in the Aerospace, Automotive, Energy, Industry and Electronics, and Medical and Life Sciences industries.

     

    In North America, Altran is based in Burlington, Massachusetts, with additional offices in Atlanta, Chicago, Detroit, New Jersey, Silicon Valley and Southern California. For more information, visit altran-na.com.

     

    Job Description:

    Altran is looking to hire a Sr. Software Engineer for an opportunity at a client site in San Diego, CA. This Engineer must be a strong technical project leader. The ideal candidate will have experience with Mergers & Acquisitions

    Job Description

    Altran is searching for 3 Quality Management Systems Consultants to help drive projects to successful completion at a client site in Bothell, Washington.

    Responsibilities

     

    In this role, you have the opportunity to Help build a high growth business that will help improve the lives of millions of people

    .

    You are responsible for

    o             Establish lean practices around Quality System Software Controls for all shared or local QMS SW systems in line applicable policies and procedures

    o             Ensure that software applications and related infrastructures are validated for their intended use by a controlled and documented process

    o             Ensure that new software and changes to existing software or infrastructures are validated before approval and use

    o             Ensure documentation of SW validation activities and results for all phases of the software system Life cycle.

    Qualifications

     

    To succeed in this role, you should have the following skills and experience

    • Understanding of current inspection practices of FDA, notified bodies and other regulatory agencies including previous interface with such bodies during regulatory assessments or inspections
    • Ability to apply current inspectional techniques to project documentation during the system lifecycle and prior to FDA inspection to ensure a comprehensive documentation package is created and maintained.
    • Effective judgment and decision making skills, typically made under stressful situations.
    • Competency in project management and the execution of multiple projects.
    • Demonstrated capability in critical thinking and leadership with strong abilities in relationship management.

    Equal Opportunity/Affirmative Action Employer; M/F/D/V

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