Senior Quality Assurance Engineer

5 days ago


Minneapolis, Minnesota, United States Omni Inclusive Full time
Senior Quality Assurance Engineer

Omni Inclusive is seeking a highly skilled Senior Quality Assurance Engineer to join our Development Quality Software team. As a key member of our team, you will be responsible for providing design control oversight to various software/system/hardware development projects.

Key Responsibilities:
  • Ensure compliance with applicable regulatory agency requirements, published standards, company policies/procedures, local procedures/work instructions, and project specific plans.
  • Provide guidance to project teams on project specific processes and deliverables. Ensure key elements of product developments are documented in design and development plan or design change plan.
  • Prepare documentation as required by product development processes, Software Development Life Cycle processes in compliance with regulatory requirements, such as FDA, ISO 13485 standards.
  • Ensure the product Design History File (DHF) is auditable, traceable, concisely organized, complete, and supports regulatory product registration needs.
Requirements:
  • Bachelor's degree in Software Engineering or related technical field with 5+ years' experience in IVD, Medical Device, or Biotechnology organization preferred
  • Working knowledge of US and International regulations and standards
  • Familiar with design control, risk management and software development processes

We are looking for a highly motivated and experienced professional who can contribute to the success of our team. If you have a passion for quality assurance and are looking for a challenging role, please submit your application.



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