Lead Quality Assurance Specialist

2 weeks ago


Minneapolis, Minnesota, United States Omni Inclusive Full time

Position Overview: The Senior Quality Assurance Engineer at Omni Inclusive plays a crucial role in overseeing design control for various software, system, and hardware development initiatives.

This hybrid role is part of the Development Quality Software team.

Key Responsibilities:

  • Ensure adherence to relevant regulatory agency requirements, established standards, company policies, and project-specific plans.
  • Guide project teams on specific processes and deliverables, ensuring that essential elements of product development are documented appropriately.
  • Prepare necessary documentation in line with product development processes and Software Development Life Cycle requirements, ensuring compliance with regulatory standards.
  • Maintain an organized and complete Design History File (DHF) that is auditable and supports regulatory product registration needs.

Essential Qualifications:

  • Bachelor's degree in Software Engineering or a related technical field with a minimum of 5 years of experience in the IVD, Medical Device, or Biotechnology sectors.
  • Alternatively, a Master's degree in a scientific field with at least 3 years of experience, or a Doctoral degree with 0-2 years of experience.

Preferred Skills:

  • Familiarity with US and International regulations and standards.
  • Knowledge of design control, risk management, and software development processes.
  • Experience in the medical device industry within a Quality Assurance capacity is advantageous.


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