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US-CA-RanchoCordova: Sr. Software Quality Engineer

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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