Altran

  • Senior Quality Assurance Analyst

    Category
    Engineering
  • 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 Detroit and the Silicon Valley. For more information, visit www.altran.com.

    Job Description

    Altran North America is currently seeking a Senior Quality Assurance Analyst in Burlington, Massachusetts. The Senior Quality Assurance Analyst participates in process improvement initiatives and provides direction within the organization through interactions with multi-discipline project teams, management, customers, and external auditors.

    Responsibilities

     

    • Working with the Head of Quality Assurance, plan and implement process improvement initiatives.
    • Work with project management and team members during the early stages of the project to establish plans, standards, and procedures to satisfy both the constraints of the project and the organization's policies.
    • Review and audit the activities, work products, process evidence (i.e. records), and create the Quality Assurance Plan for client engagements and company functions to verify that they comply with the applicable procedures and standards.
    • Participate in audits in support of ISO 9001 and ISO 13485 certifications.
    • Develop and deliver QMS training
    • Occasionally travel (up to 25%) to other Altran or client locations to assess/audit customer processes for software and hardware in scope for the project

    Qualifications

     

    • 5+ years of experience within a QA role, with a working knowledge of medical device regulated processes – e.g., 21 CFR 820
    • Knowledge of relevant international standards – ISO 14971, IEC 62304, IEC 60601, ISO 270001
    • Strong written and interpersonal communication skills
    • Ability to manage competing priorities
    • Ability to evaluate process tradeoffs
    • Bachelor’s Degree in a technical subject matter
    • ASQ certification is a plus

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

     

     

     

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed