Senior Quality Engineer (Software/Cyber)

Salt Lake City, Utah, United StatesSalt Lake CityUtahUnited StatesNorth AmericaMarch 4, 2023

Mission: Create solutions as part of the Epitel product development and production teams through the application of Quality engineering skills for medical devices. Play an active role from product inception through product launch and maintenance, ensuring that products meet all design control and regulatory requirements. Develop processes to ensure product quality, oversee corrective and preventive actions, identify root causes of problems, and generate solutions.


  • Provide leadership and guidance through product design and development phases.
  • Provide Quality System guidance to projects and programs, particularly in product development to ensure compliance to relevant Quality System requirements
  • Support or Lead CAPA activities, including root cause analysis, development of corrections and corrective actions, implement changes and monitor effectiveness
  • Perform analyses on various types of data, such as post market surveillance, test, process verification or validation to identify trends or other conclusions
  • Lead and support software quality engineering activities, based on working knowledge of various Software Development Life cycle (SDLC) models
  • Lead and support software verification and validation activities including protocol development or review and report development and review
  • Develop plans for verification and validation of Product software, Production and Quality Systems Software and Software of Unknown Provenance
  • Test method/test case development
  • Post-market analysis and reporting
  • Identification of Quality metrics for complaint trending and production applications
  • Technical writing
  • Perform and lead Risk Management activities throughout product lifecycle
  • Apply statistics and process/design excellence tools to establish test plans and evaluate data and processes
  • Support establishment of QMS processes and refinement/remediation of pre-existing QMS processes
  • Internal audit of QMS
  • Apply problem-solving methods for root-cause activities
  • Supplier quality management, evaluation and control
  • Support FDA and EU MDR submissions activities



  • Understanding of coding and development principals
  • 5-8 years in quality engineering supporting product development in the medical device industry
  • Bachelor’s degree in a STEM field of study – Master’s degree preferred
  • ASQ CQE preferred
  • Strong understanding of IEC 60601, 62366, 62304, ISO 14971, ISO 13485
  • Strong understand of 21 CFR Part 820
  • Understanding of FDA Guidance for Pre/Post-Market activities for Cybersecurity
  • Understanding of basic principles of Reliability engineering
  • Experience with statistical applications
  • Excellent communications and technical writing
  • Detailed oriented, high energy, self-starter, who exercises sound judgment and deliver against company business goals and objectives
  • Experience with MDSAP
  • Experience with EU MDR
  • Experienced in definition of Quality metrics and post-marketing analysis
  • Audit readiness and support experience

Role-based competencies (as many role-based competencies as we think appropriate to describe the behaviors someone must demonstrate to achieve the outcomes. We want specialists for these roles rather than generalists. We’ll be looking for these in our interviews.). Examples include:

  • Ethical, honest, committed, strong moral compass
  • Detailed, focused, organized, able to understand complexity
  • Clear communicator, able to simplify challenging topics, persuasive, comfortable working in a team
  • Willingness to say no and, conversely, willingness to help identify solutions
  • Able to handle confrontation without becoming confrontational
  • Dedicated to their team, experienced quality leader
  • Versed quality practices and policies, with a track record in device and software development
  • Consistently applies technical principles, theories, concepts and quality sciences / tools


  • Equity - every employee shares in Epitel’s success.
  • Professional development allowance - we do better when you do better
  • Medical/dental coverage - we pay 100% of premiums
  • SimpleIRA contribution
  • Unlimited vacation - we also take typical US holidays + Pioneer Day (harkening to our Utah roots!)
  • Regular IRL meetings - remote work is convenient, but it’s important to get to know one another in-person. We organize time for us to all to be physically in the same place (as long as we’re all safe) every once in a while.

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