Senior Quality Engineer

Job Description
Insight Global is looking for a Senior Quality Engineer to support a new product development project. This role is responsible for managing risk management documentation across the product lifecycle, including maintaining risk files for marketed products, supporting the development of new product risk documentation, and improving overall risk management systems. The position ensures compliance with ISO 14971 and regulatory requirements by reviewing submissions, responding to regulatory inquiries, and staying current on evolving standards. It also supports audits, monitors risk metrics, and escalates changes in product risk profiles as needed. The role partners cross-functionally with teams such as Medical Safety, Manufacturing, and Post-Market Surveillance to ensure alignment, while providing regular reporting, facilitating meetings, and driving continuous process improvements.

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