US-CA-SanDiego: Sr Software Quality Engineer

To see other opportunities, please visit http://sqa.fyicenter.com
Date: 11-Jul-2011

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.

To apply for this position, please visit this Website.

Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com