Dohmen Life Science Services

  • Quality Engineer I

    Job Locations US-CO-Wheat Ridge
    Job ID
    2018-2057
    # of Openings
    1
    Category
    Consulting
  • Overview

    OUR COMPANY:

    Since 1858, Dohmen has been driven by the desire to get safe and effective treatments and cures to the people that need them most.  As entrepreneurs, we’ve looked for new and better ways of doing this year after year. Today, as Dohmen Life Science Services, we bring the industry’s most comprehensive service array to Medical Device, Biotech and Pharmaceutical entrepreneurs, helping them get farther faster and keeping them focused on innovations that improve lives. 

     

    Our behavior is guided by five simple values –

    Caring: We are empathetic and respectful.  We ask “how can I help you”

    Committed: We are dedicated and persistent.  We ask “how can I make it happen”

    Creative: We are inventive and imaginative. We ask “how can I do it better”

    Collaborative: We are cooperative and share our knowledge. We ask “how can we achieve success” 

    Courageous: We’re willing to risk failure over inaction. We ask “how can I challenge myself”

    This perspective defines us. How we act, how we do business, how we work with our clients and how we work with each other. They are essence of what makes us successful. They are what set us apart. 

     

    THE POSITION

    The most important aspect of the position of Quality Engineer is the responsibility to focus on several industries regulated by the FDA including medical device, and tissue and blood banking.  This position is responsible for managing the execution of quality processes and quality systems for DLSS’ external clients.

     

    POSITION SUCCESS FACTORS

    • Ability to work with internal employees and external clients simultaneously
    • Ability to manage multiple projects and deliverables in a timely fashion

     

    ESSENTIAL FUNCTIONS

    • Participating on project teams as a contributing member by providing quality engineering support in the development of new products and processes, and continuously improving medical device products
    • Contributing to the development of verification & validation plans, testing, and generation of test reports
    • Leading and/or participating in the development of the risk management process
    • Participating in the compilation and review of technical documentation for both domestic and international regulatory submissions
    • Assisting project teams on compliance with design control requirements per FDA QSR, European MDD, ISO 13485 and other applicable ISO/EN standards
    • Facilitating and performing internal QA audits as required

    Responsibilities

    Responsibilities

    • Reviewing submitted proposals to determine if new equipment relating to a customer’s needs, testing or V&V activities should be purchased and controlled.
    • Participating in the execution and maintenance of DLSS’ Quality Management System as requested by DLSS’ Management Team.
    • Analyzing reports and returned products and recommending corrective/preventive actions (CAPAs)
    • Performing statistical analysis to assess cost of, and determining the responsibility for products or materials that do not meet required standards and specifications
    • Helping to mentor DLSS’ engineering interns as appropriate

     

    MINIMUM KNOWLEDGE, SKILLS AND ABILITIES REQUIRED

    • BS degree in Engineering is required.
    • Working knowledge of GMP and ISO 13485 Quality System preferred
    • Experience in medical device capital equipment industry preferred
    • Experience in one or more of the following necessary: auditing, design review, sterilization, project management (product development team participation)

     

     

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