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Senior Software Quality Engineer

Protingent

Redmond, WA

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JOB DETAILS
SKILLS
Aerospace and Defense, Analysis Skills, Artificial Intelligence (AI), Biomedical Engineering, Bug Tracking/Defect Management, Clean Technologies, Code Reviews, Code of Federal Regulations, Communication Skills, Computer Science, Continuous Improvement, Customer Support/Service, Documentation, Documentation Plan, FDA (Food and Drug Administration), FDA Requirements, ISO (International Organization for Standardization), Information Technology & Information Systems, International Electro-Technical Commission (IEC), Internet Security, Maintain Compliance, Medical Equipment, Problem Solving Skills, Process Improvement, Product Design, Quality Assurance Software, Quality Engineering, Quality Management, Regulatory Compliance, Reporting Skills, Requirements Management, Risk Analysis, Software Architecture Design, Software Configuration Management, Software Design, Software Development, Software Development Lifecycle (SDLC), Software Engineering, Software Testing, Source Code/Configuration Management (SCM), Test Plan/Schedule, Testing, Traceability, U.S. National Institute of Standards and Technology (NIST), United States Citizen, Verification Plans
LOCATION
Redmond, WA
POSTED
3 days ago
Position Title: Senior Software Quality Engineer

Position Description: Protingent Staffing has an exciting direct hire Senior Software Quality Engineer opportunity.

Job 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.

Job Qualifications:
  • 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.

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


About Protingent: Protingent is an Award-Winning provider of top-tier Engineering and IT talent, trusted by companies at the forefront of innovation — from Software and Aerospace to AI, Clean Tech, Medical Devices, and Connected Technologies. We’re passionate about making a positive impact by connecting exceptional talent with meaningful opportunities and helping our clients build the future.

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