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US-CA-San Diego: Software Verification and Validation Manager
To see other opportunities,
please visit http://sqa.fyicenter.com
Date: 04-Sep-2008
Software Verification and Validation Manager I-II
DESCRIPTION OF POSITION RESPONSIBILITIES:
* Plans, develops, coordinates and directs multiple projects or a project of major scope and impact; determines staffing needs for project.
* Troubleshoots product or project problems, improvements or field complaints.
* Responsible for root cause analysis.
* Experience using Use Cases.
* Interface with project teams; produce project schedules and status reports.
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Supports Regulatory Affairs for 510(k).
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Create and maintain FDA design control documentation; assist in preparing SW portion of FDA submissions.
* Perform system analysis, requirements discovery, safety risk analysis and requirements analysis.
* Develops software validation procedures and guidelines and ensure they meet FDA guidelines.
* Develops V&V technical plans and protocols and reviews deliverables for complex SW projects.
* Interfaces with programming staff, QA, RA and PMO to ensure project completion.
* May lead project teams to select methods for obtaining desired solutions for each project.
* Ensures team compliance with SOPs for regulatory compliance and business systems management.
* Executes complex test protocols.
RELATED BUSINESS/TECHNICAL SKILLS, KNOWLEDGE, ABILITIES:
* Working knowledge of applicable programming languages, object oriented environments and Pre-emptive multitasking applications.
* Working knowledge of FDA software validation guidelines.
* Working knowledge of evaluation methods in the design, development and debugging of SW programs.
* Working knowledge of IEEE standards, black box testing, communication protocols, Windows and various test methodologies.
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Solid understanding of the SW development life cycle.
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Solid understanding of HW and SW concepts.
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Familiar with e-SAS or similar programs.
EDUCATION AND EXPERIENCE REQUIREMENTS:
* Strong communication & leadership skills.
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Experience with strategic planning & ability to see “big picture” opportunities & solutions.
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Typically requires a BS degree or equivalent and a minimum of 8+ years related experience
For more information, please write to us.
Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com
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