US: Software Quality Engineer To apply for this position, please visit this Website. http://sqa.fyicenter.com/jobs/99665457_Software_Quality_Engineer_.html 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 Thank you, Team SQAFYI - Software QA Resource FYI http://sqa.fyicenter.com -- You received this message because you are subscribed to the Google Groups "Software Quality Assurance Center" group. To post to this group, send email to [email protected]. To unsubscribe from this group, send email to [email protected]. For more options, visit this group at http://groups.google.com/group/software_qa_center?hl=en.
