SQAFYI - Software QA Resource - FYI

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;

Bachelorís 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

US: Software Quality Engineer