Senior Software Quality Engineer
Protingent
Job Description Position Title: Senior Software Quality Engineer Position Description: Protingent Staffing has an exciting direct hire Senior Software Quality Engineer opportunity. Job Responsibilities:
Job Qualifications:
Job Details:
- 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.
Vacancy posted 3 days ago
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