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Senior Quality Engineer

Company: Katalyst Interactive Inc.
Location: Las Vegas
Posted on: January 16, 2022

Job Description:

The Scoop

As Senior Quality Engineer at Katalyst, you'll have the opportunity to help launch a world-changing health & fitness company. Were looking for someone to lead our quality control efforts to ensure regulatory compliance and ongoing customer satisfaction. If you have a knack for keeping products compliant and have passion for all things sports performance, fitness, and consumer tech, lets talk!

About Us

Katalyst is the worlds most efficient workout. Our FDA-cleared training system and full-body suit use Electro Muscle Stimulation (EMS) to deliver specifically-tuned, low-frequency impulses to each of your major muscle groups. These impulses imitate the brain signals that cause your muscles to contract and significantly increase your muscle activity. When combined with simple, bodyweight movements, Katalyst multiplies the results of any exercise. The result is a complete, full-body workout in just 20 minutes, with no external weights or impact on your joints. Learn more at www.katalyst.fit.

Responsibilities include, but are not limited to:

  • Manage pre-production design assurance/quality engineering activities as they relate to product lifecycle development
  • Participate in formal design reviews, ensuring design control requirements are met
  • Providing Test Method Validation expertise for internal teams and assisting with the design of method validation activities
  • Compiling and analyzing validation data, prepare documentation, and make recommendations for changes and/or improvement
  • Working closely with engineering departments to ensure high-quality, compliant design inputs and outputs
  • Ensure compliance to design controls, documentation procedures to FDA regulations and internal Katalyst procedures
  • Leads risk analysis discussions at all levels to ensure product quality and reliability
  • QA leadership in development of receiving inspection processes
  • Stay up-to-date and follows all Quality System procedures related to this job, which can affect the quality of products or services provided to our customers
  • Proactively owning and driving process improvements
  • Collaborate with Suppliers and Manufacturers to assist with the development of manufacturing, testing processes and associated documentation

    Requirements

    The ideal candidate will have:
    • Bachelor's Degree in Engineering (mechanical, electrical, software preferred)
    • Knowledge and experience with firmware and software development and the processes associated with product life-cycles
    • 5+ years experience within FDA regulated environment, 2 years within a Quality related field
    • Strong Working knowledge of medical device regulations (including FDA QSRs, ISO 13485, CE)
    • Strong working knowledge of design controls and design transfer requirements
    • Ability to create and review documentation to meet internal and regulatory requirements
    • Ability to create robust test protocols for electronic devices to applicable requirements
    • Excellent verbal and written communication skills
    • Experience with Customer Feedback and CAPA processes including investigational techniques
    • Familiar with one or more risk management techniques (i.e. Hazard Analysis, Risk Analysis, Failure Modes and Effects Analysis (FMEA), Fault Tree Analysis (FTA), etc.)
    • Able to work, influence and lead in a highly cross-functional team environment
    • Ability to work independently on tasks as a subject-matter expert and report progress
    • Ability to work with global suppliers to endure compliance to manufacturing quality controls

      Benefits

      At Katalyst, the health and well-being of our employees is of the utmost importance to us. We offer the following to all full-time employees:
      • Competitive salary and stock options
      • Medical, Dental, and Vision
      • Unlimited PTO
      • Flexible remote work policy
      • Parental/Family leaveby Jobble

Keywords: Katalyst Interactive Inc., Las Vegas , Senior Quality Engineer, Engineering , Las Vegas, Nevada

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