US-PA-Leetsdale: Software and Medical Quality Engineers
To apply for this position, please visit this Website.
http://sqa.fyicenter.com/jobs/99670707_Software_and_Medical_Quality_Engineers.html
To see other opportunities, please visit http://sqa.fyicenter.com
Date: 09-Dec-2010

Software and Medical Quality Engineers

The Software Quality Engineer will provide QA Engineering support for
existing products and products in development, as well as provide
support for various Quality Management System programs. This role
investigates non-conformances, defects and process failures in order
to identify areas in need of process improvement, to determine the
cost of quality and to lead or participate in resolution. This
position will oversee the evaluation, selection and usage of metrics
tools and methodologies, such as Six Sigma and Lean Manufacturing and
will assist with maintaining the site quality metrics reporting
system, ensure that quality metrics data are identified and monitored,
and periodic trend reports are developed and distributed.
Additionally, the Software Quality Engineer will lead and support
customer, regulatory body, supplier and internal audits and manage and
execute the program. The ideal candidate will have at least 5 years of
medical device or pharmaceutical Quality Engineering experience,
proven expertise in quality engineering practices and quality system
regulations and a thorough understanding of FDA/ISO 13485 standards
and regulations. You must have proven technical skills to enable
critical review of software development and testing processes and
methods and the ability to communicate in technical matters with
internal associates, customers and suppliers. You must be proficient
in Microsoft Office, Microsoft Project and Visio. Additionally, this
position requires approximately 15% travel.


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

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