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Associate Staff Quality Engineer - Software Development
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- Quality Engineering Support for product software Design Control Process -Implement/facilitate product risk management planning as needed.
- Facilitate and participate in product software design reviews, develop quality engineering deliverables, and assure Design History File (DHF) is updated, as necessary.
- Participate in technical or specialty design review(s) for product development and participate as QA representative in the design change management process for product development.
- Assists in the development, review, and execution of quality management system areas (e.g. change control, document control, risk analysis, design control, verification and validation, etc
- Contribute to maintain compliance to quality systems and programs in the areas of change management, design control, product verification and validation, initiating CAPAs for relevant design issues, etc, to ensure compliance with FDA and regulatory requirements.
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