US: Software QA Engineer
To see other opportunities,
please visit http://sqa.fyicenter.com
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
Team SQAFYI - Software QA Resource FYI