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