Senior Software Quality Engineer

Senior Software Quality Engineer Responsibilities

• Create and execute detailed software verification plans and protocols.
• Quality oversight of software development lifecycle activities (requirements quality, design reviews, code review processes, defect triage, release readiness).
• Write software verification reports appropriate for FDA submission.
• Maintain traceability to ensure that software products meet design specifications and quality expectations.
• Ensure compliance with FDA regulations (21 CFR Part 820), IEC 62304, and ISO 14971 standards in quality assurance activities for software.
• Participate in risk and cybersecurity analyses.
• Perform or participate in quality reviews for a wide range of software documents, including plans, requirements, architecture, design, and software release documentation, as well as risk and cybersecurity analyses.
• Ownership or oversight of software configuration management practices, including version control, baselines, and release documentation.
• Drive continuous improvement of software quality processes.

• Bachelor’s degree or higher in Computer Science, Software Engineering, Biomedical Engineering, or a related field.
• At least 5 years of experience in software quality assurance or software test engineering, including experience in the medical device industry.
• Strong knowledge of the software development lifecycle.
• Experience with software configuration management and release governance.
• Working knowledge of FDA regulations 21 CFR Part 820, IEC 62304, and ISO 14971 standards.
• Demonstrated expertise in software verification, including developing and executing test plans and protocols.
• Excellent communication skills, with the ability to effectively convey technical information to diverse stakeholders.
• Familiarity with cybersecurity frameworks (e.g., FDA premarket cybersecurity guidance, NIST CSF).
• Strong analytical and problem‑solving skills.

• Type:
  Direct-Hire
• Salary:
  Market Rate
• Location:
  
  Redmond, WA (Onsite)
• Required US Citizen or Green Card Holder.