US-MA-Burlington: Software Quality Engineer

To see other opportunities, please visit http://sqa.fyicenter.com
Date: 14-Dec-2009

Software Quality Engineer

* Candidates will have at least 10 years of experience with software development or testing, and at least 7 years of experience in software quality engineering within the medical industry with regulated products. * Must be a team leader who can develop, design, and execute a plan to ensure the quality of software products in manner consistent with FDA's 510(k) development guidelines and the QSR (21 CFR 820). * Candidates must have strong skills in written communication, team building, negotiation and conflict resolution. * Candidates must be committed to building and fostering strong teamwork and engineer buy-in. * Candidates must demonstrate facility with the techniques and tools of software quality engineering. * Experience with DOORS or Requisite Pro a plus.

Responsibilities

* Leads the software quality effort as an integral member of the software development team. * Participates as an individual contributor, and oversees the software quality engineering process during the software development lifecycle. * Activities include requirements review and assessment, traceability analysis, test development, white box and black box testing. * Ensures that custom software development projects are carried out in accordance with the QSR (21 CFR 820) and FDA 510(k) guidelines.

To apply for this position, please visit this Website.

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