Software Quality Assurance Engineer


This role is responsible for establishing, executing and maintaining software quality assurance standards and measures across the organization. This position will apply proven analytical, problem-solving and quality assurance/testing skills to maximize the benefit of business investments in software initiatives and ensure products are designed, developed, tested and manufactured in accordance with applicable regulatory requirements, customer/patient expectations and best practice industry standards.

Essential Responsibilities:

  • Participate in all phases of the project life cycle (e.g., requirements development/review/approval, test planning, test execution, and test reporting and assessment
  • Plan, monitor and manage all SQA and testing activities throughout the project lifecycle
  • Prepare test plans through characterization of testing evolutions – system, integration, functional, performance, regression testing and user acceptance
  • Manage test schedules and track and communicate testing progress to project stakeholders
  • Implement and lead routine reviews with project stakeholders to ensure all deliverables meet expectations and timeline commitments
  • Collaborate with R&D Software and IT to analyze complex challenges and recommend solutions to stakeholders and project team
  • Partner with R&D Software and IT to develop standards and best practices to improve efficiency and over-all quality of work delivered by the project team
  • Support compliance assessments to ensure quality and regulatory requirements are successfully implemented and maintained
  • Serve as Subject Matter Expert for regulatory inspections related to Software Quality Assurance



  • BS Degree in Mechanical, Electrical or Biomedical Engineering or equivalent 4 year degree


  • 5+ years software quality (SQA) experience
  • 3+ years Class II or Class III medical device experience
  • Demonstrated knowledge of FDA Quality System Regulation, ISO 13485 Quality Management System and ISO 14971 Risk Management for Medical Devices
  • Expertise related to software validation requirements in the medical device industry or other highly regulated industry
  • Strong organizational skills and ability to prioritize workflow to meet established time frames and schedules
  • Able to constructively collaborate with cross-functional teams
  • Software testing experience related to medical device industry
  • Working knowledge of quality assurance methodologies
  • Ability to follow instructions, work independently, or function in a team as needed
  • Knowledge of commonly used concepts, practices and procedures for full product development life-cycle                   


  • Experience with electro-mechanical devices
  • ASQ Certification (Certified Quality Engineer, Certified Quality Manager)
  • Demonstrated ability to act as Subject Matter Expert related to Software Quality Assurance
  • Experience supporting regulatory agency inspections and Notified Body Audits in an SME role


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