US-CA-SanDiego: Sr Software Quality Engineer
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Sr Software Quality Engineer
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
Required Skills: -Must possess and teach fundamental understanding of quality philosophies, principles, methods, tools, standards, organizational and team dynamics, interpersonal relationships, and professional ethics.
-Must possess and teach an understanding of software quality management principles and demonstrate a comprehensive knowledge of developing and implementing software quality programs, to include tracking, analyzing, reporting, problem resolution, and training.
-Must possess knowledge of software development and maintenance processes and methods.
-Must possess a basic understanding of project management principles and techniques as they relate to software project planning, implementation, and tracking.
-Must have a thorough understanding of software inspection, testing, verification, and validation.
-Must have a basic understanding of how and when to perform software audits including audit planning, approaches, types, analyses, reporting results, and follow-up.
-Must possess a basic understanding of the configuration management process to include planning, configuration identification, configuration control, change management, status accounting, and reporting.
Required Background • Experience with Software Verification and Validation Methodologies • Experience with FDA Regulations CFR 820 and Part 11 • Experience with ISO13485/QSR.
Preferred Educational Background: • BS/BA or equivalent in Engineering, Biological/Life Sciences, Chemistry or related field required. • Graduate degree preferred.
Preferred Experiential Background: • 7+ years relevant experience required. • Experience conducting compliance audits, microbiological testing, immunological testing or optical scanning. • Experience with FDA Regulations CFR 820 and Part 11 • Experience with ISO13485/QSR. • Excellent attention to detail, well organized and able to work independently and in teams. • Excellent interpersonal, verbal and written communication skills. • Knowledge and skills typically acquired through previous positions in fast-paced corporate environments which involved responsibility for similar work.
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Team SQAFYI - Software QA Resource FYI