[Outsource:59865] US: Software Quality Engineer

US: Software Quality Engineer
To apply for this position, please visit this Website.
http://sqa.fyicenter.com/jobs/99664968_Software_Quality_Engineer.html
To see other opportunities, please visit http://sqa.fyicenter.com
Date: 16-Feb-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;

13.) Familiarity with MySQL for SQL queries;

14.) Experience with Rational RequisitePro ;

15.) Bachelor's degree in Engineering or Science

16.) 4-6 years of HANDS-ON experience in the medical device industry
in a Software Quality Engineering role or equivalent

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

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