Quality Systems Engineer Responsibilities and Duties

Provide support for product assurance from design effort to initial product qualification followed to first phase production.

Interact with production and engineering personnel to setup production test requirements and new product qualification.

Review test plans and methods related to quality systems.

Involve in test equipment design and activities and conduct product failure analysis.

Establish crucial product characteristic and performance metrics.

Provide process capacity analysis and prepare processes to promote feedback and corrective actions for fresh transitioning products.

Revise and validate test equipment for operation readiness.

Support production readiness review efforts essential for QA.

Assist in development of work instructions along with route sheets for entire assigned programs.

Support Business Engineering and Development for Request for Proposal (RFP) response efforts.

Revise and evaluate data to identify report ability and CAPA decisions.

Submit events to be reported with regulatory authorities on given timeframe as dictated by regulations.

Ensure implementation and documentation associated with field corrections are sufficient and effective.

Support external and internal audits to protect decisions and clarify programs and processes.

Prepare and execute procedures to conform to industry and corporate standards.

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