US-PA-Leetsdale: Software and Medical Quality Engineers

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.

To apply for this position, please visit this Website.

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