Cambridge Categories:
Software QA Engineer Outcome Software, Inc.
THIS JOB HAS EXPIRED
DescriptionIn late 2011, Quintiles, a leader in interventional IIIb/IV studies and the only fully integrated biopharmaceutical services provider offering clinical, commercial, consulting and capital solutions, acquired Outcome, the unparalleled experts in observational research. Together, Quintiles Outcome offers the expertise and experience in real-world and late phase research you need to determine the right approach for the right question, to achieve your research objectives. Whether monitoring safety and evaluating benefit-risk or demonstrating effectiveness and gaining market access or proving efficacy in new indications/new formulations, our experts provide you with the most comprehensive approach to evidence development.
Primary Responsibilities:
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.
Qualifications
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
Primary Location: USA-Massachusetts-Cambridge
Organization: USA02 - US Clinical Development Svcs
| Location: | Cambridge, MA United States |
|---|
THIS JOB HAS EXPIRED
Outcome Software, Inc.
All Jobs: at Outcome Software, Inc.| Web Site: | www.outcome.com |
|---|---|
| Headquarters: | 00000 United States |
| Industry: | Healthcare Services |
Support Outcome Software, Inc. with Social Media services
Find more Software QA Engineer jobs
