Date: _07-Dec-2011_
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Sr. Software Quality Engineer
* Develops and refines software quality assurance methodologies/lifecycle process and procedures in accordance with global medical device regulations.
* Provides guidance and direction to global project teams regarding the application of procedures.
* Participates in cross functional meetings for new product development, manufacturing and/or GxP projects as appropriate. Assures that all activities are completed and meet requirements including but exclusive to: project plans, test plans/reports, requirements documents, risk assessments, traceability matrices and verification/validation summary reports
* Benchmarks best practices and regulatory changes in expectations
* Assists in the development of software requirements, test plans or key documents, as required.
* Leads the risk assessment and risk management process
* Create and qualify a rework process to salvage high value components
* Requires a Bachelor's degree in Software Engineering, Computer Science, Mathematics or other technical degree with appropriate experience
Knowledge and Experience:
* Requires 8+ years experience in Software Quality Assurance in the medical device industry
* Proven experience in leading others with a proactive attitude
* Demonstrated knowledge and understanding of FDA regulations, Quality System Regulations (QSR), ISO 13485/14971 requirements
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Thank you,
Developer FYI Center
http://dev.fyicenter.com/