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US-MI-Troy: Software Quality Assurance Engineer
To see other opportunities,
please visit http://sqa.fyicenter.com
Date: 12-Mar-2009
Software Quality Assurance Engineer
DESCRIPTION
* Establish, implement, and maintain the software quality assurance program to ensure that the software development, risk management, configuration management, verification/ validation activities and the documentation and problem resolution processes meet domestic and international regulatory requirements.
* Establish and maintain a software problem resolution process to include bug/anomaly reporting, analysis and corrective action.
* Review and participate in the preparation of software design documentation, software verification and validation documentation and software unit level testing and/or integration testing activities.
* Participate in the risk analysis process by proposing methods and tools for software risk analysis and mitigation management and review and approve risk management reports.
* Coordinate and ensure execution of software verification and validation activities of multiple projects.
REQUIREMENTS
* Knowledge and proficient in the use of software development and process monitoring tools such as version management, build, requirements, tracking and manual and automated test.
* Extensive record of working on cross functional teams, writing and developing software process strategies plans, and process documentation.
* Knowledge / experience with some of the following listed in order of preference: IEC 62304 or AAMI SW68, AAMI TIR32, and FDA General Principles of Software Validation.
* BS Degree of scientific discipline or in Computer Science.
* 5+ years of software quality engineering experience in a production and product development environment.
PREFERRED
* 3+ years in the Medical Device Industry.
* Proficient technical writing skills.
Required Skills:
SOFTWARE QUALITY ASSURANCE
To apply for this position, please visit
this Website.
Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com
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