US-DC-Baltimore: SOFTWARE QUALITY ENGINEER
To apply for this position, please visit this Website.
http://sqa.fyicenter.com/jobs/99670244_SOFTWARE_QUALITY_ENGINEER.html
To see other opportunities, please visit http://sqa.fyicenter.com
Date: 13-Jan-2011

SOFTWARE QUALITY ENGINEER

This position is responsible for product and non-product software
validation and risk assessment using guidance from U.S. and
international guidance and standards. Assuring that software
development is performed and documented using a software life cycle
approach as well as supporting the development of regulatory
submissions for products containing software are within the scope of
this role. This position will also be responsible for facilitating the
development, implementation and monitoring of software related quality
programs, plans, SOPs and policies that ensure the development and
maintenance of Quality System in compliance with corporate policies,
GMP, FDA regulations, ISO 13485:2003, and other regulatory
requirements as applicable.

A M.S. or B.S. degree in a technical/scientific/engineering
discipline, with at least 7 years of experience in medical devices, in
vitro diagnostics, pharmaceuticals or a related industry are required.
Experience working with the FDA and/or ISO auditors as well as new
product submissions for products containing software is required. ASQ
certification (CQE, CRE, CQA) is preferred. Candidates are expected to
possess excellent working knowledge and experience of the FDA’s
Quality System requirements (QSR), ISO 9001 and ISO 13485:2003
standards. Quality assurance experience in software is a plus.
Candidates should possess the ability coordinate multiple projects and
multi-task in an environment with changing priorities. Strong
analytical, communication (linguistic, grammar, and editing skills)
and interpersonal skills are a must. Proficiency with Microsoft
applications (Word, Excel, Project, PowerPoint, and Outlook), and the
ability to learn additional software applications as the need arises
are a must.


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

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