Senior Quality Engineer, Medical Devices & Design Controls

A medical device manufacturer is seeking a Quality Engineer to serve as a representative on cross-functional teams, leading Design Control activities. The role requires 7 to 10 years of experience in the medical device industry with expertise in quality oversight and risk management. Responsibilities include ensuring compliance with FDA regulations and ISO standards, providing oversight of design verification and validation processes, and supporting the development of medical device software.

Ideal candidates will possess strong communication skills and a background in statistical analysis.
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