Software Quality Assurance Specialist

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http://sqa.fyicenter.com/jobs/99680568_Software_Quality_Assurance_Spec...ist.htm
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Date: 06-Nov-2008



Software Quality Assurance Specialist

Responsibilities will include: . Coordinate development of the
software project plan with software project personnel, including the
development of the project audit schedule that will provide the
project team with insight into compliance with internal processes and
external regulations. . Provide advice to the software development
team regarding software process implementation on the project, as well
as answer questions about software processes and process compliance
issues throughout the project lifecycle. . Plan for and gather the
necessary data for completing individual software process or work
product audits based on the defined audit schedule. . Conduct software
process and work product audits based on document reviews and
interviews with appropriate members of the project team. Provide the
results of the software process and work product audits to the
software development team and SQA management in order to provide
insight into project compliance with established plans, policies and
procedures. Track software project non-compliances to closure. .
Support the software peer review and design review process through
participation in scheduled reviews as requested. . Monitor software
development, maintenance, and SQA audit process documentation
(policies, procedures, and worksheets). Document and submit revision
suggestions to existing software processes and help develop new
processes as needed based on changes to the overall software
development process. . Manage the implementation, administration,
training, and maintenance of quality system related software
applications from inception through retirement.

Job Experience: We are looking for an individual that meets the
following criteria:

.. 8 years or experience in a software development environment, with
technical software engineering experience (design, coding, testing)
essential. . Experience in auditing would be highly preferred. .
Extensive knowledge of the external regulations and standards such as
FDA 21 CFR Part 820 (QSRs), 21 CFR Part 11, ISO 13485 and the software
processes in a medical device regulated environment would be
exceptionally helpful. . Excellent communication and writing skills,
strong negotiation skills and skills associated with being an
effective change agent.



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