US: Software QA Engineer

To see other opportunities, please visit http://sqa.fyicenter.com
Date: 06-Nov-2012

Software QA Engineer

* Assist in quality assessments of our product and development practices during all phases of product development to ensure compliance with all FDA requirements. * Assist SQA Manager in evaluating the company's validation processes, make recommendations, and help implement change when necessary. * Implement Black Box API and White Box test suites for our products, automated whenever possible. This includes functional, regression, stress and scalability test suites. * Participate in the development of all test plans and test scripts for all new releases and new revs of OS projects. * Perform all validation testing for new programs and new revs of existing programs, including anomaly regression testing. * Develop and maintain expertise in and company knowledge base of all applicable Federal and State regulations regarding healthcare data such as HIPAA guidelines and CFR21Part11. * Participate in customer audits of product quality systems for all released products. * Help to conduct audits of external contractors and technology providers. * Work closely with Development and Project Managers to help define, spec, implement and validate a project from start to finish. * Assist in technical support as needed to help resolve complicated issues. * Aid in developing new and editing existing SOP's as needed.

* B.S. in Computer Science or related major desired * 5 or more years experience in Software or SQA engineering, validation of software products, and writing test plans and test scripts * Exposure to automated testing tools, QTP preferred * Interest in and understanding of SQA methodologies * Excellent communication skills, both verbal and written * Experience working with pharmaceutical, biotech or medical device companies · Understanding of ISO 9000, GCP, and 21 CFR Part 11 is preferred

To apply for this position, please visit this Website.

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