US: Software Quality Engineer
To see other opportunities,
please visit http://sqa.fyicenter.com
Date: 09-Jan-2012
Software Quality Engineer
1.) Experience in an FDA/ISO 13485 Regulated environment; thorough knowledge of GMP regulations: 21 CFR Part 820, 21 CFR Part 11
2.) Experience reviewing requirements from stake holders, and ensuring appropriate documentation of the requirements;
3.) Experience translating risk analysis results into design requirements, and reviewing the translation of the requirements into formal engineering specifications;
4.) Experience leading formal risk analysis activities compliant with ISO 14971:2007
5.) Experience creating Verification and Validation Protocols from engineering specifications ;
6.) Experience performing software verification testing; white and black box methods;
7.) Experience creating Verification and Validation Test Reports and, Verification and Validation Summary Reports;
8.) Ability to critically review Design Review packages and provide actionable feedback;
9.) Able to perform Requirements Traceability;
10.) Ability to read/understand JAVA and C#, for performing white box testing and code reviews;
11.) Familiarity with relational databases;
12.) Good understanding of MS office, Windows XP, Vista, Server 2003, Windows 7 operating systems and networking principles, SharePoint 2007/2010;
Bachelor’s degree in Engineering or Science
2.) 4-6 years of HANDS-ON experience in the medical device industry in a Software Quality Engineering role or equivalent
To apply for this position, please visit
this Website.
Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com
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