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Quality Engineer II

Edwards Lifesciences · Draper, Utah, US

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives.

Job description

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Quality Engineer II position is a unique career opportunity that could be your next step towards an exciting future. Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. How You'll Make an Impact: Investigate moderately complex manufacturing product quality and compliance issues which may include: Investigate PRAs and complaints for manufacturing related issues Manage site NCRs, CAPAs , ECRs and audit observations for all production processes prior to final product release based on engineering principles; analyze results, Provide technical support to external land internal audits, Make recommendations and develop reports. Oversee product release,...