Sr Quality Engineer

Job DescriptionRoles & Responsibilities: 50% involvement in supporting manufacturing operations.25% in product changes or new product introduction projects.15% failure investigation.10% performing complex inspection and project management.Develop and apply corporate level quality metrics.Support line transfers between Intuitive buildings and regions.Handle projects of various product and subsystem types (Instruments, Accessories, product improvements, etc.).Plan and direct creation of quality standards, quality control, and quality assurance procedures, sampling plans, test methods, fixtures, and processes for finished devices manufactured at ISI Mexicali, and OEM suppliers, utilizing clinical and engineering knowledge.Ensure process compliance through the design and development of comprehensive procedures including work instructions, flowcharts, forms, templates, checklists, and other product or process related documentation for recording, evaluating, and reporting quality data.Develop and implement methods and procedures for disposition of discrepant material.Provide support to commercial product manufacturing processes, including failure analysis, documentation review and approval, tooling qualification, and defect containments.Provide quality expertise post market release to the quality engineering support team to analyze the returned product.Perform deep technical failure analysis based on the physics of failure.Review and interpret complex data analysis rooted in an understanding of our product hardware and software, the physics of failure, and the use conditions in the clinical / operating room environment.

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