SQAFYI - Software QA Resource - FYI

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

US: Software QA Engineer