Job Description
The Opportunity
This position works out of our Zona Franca Coyol Alajuela location in the Structural Heart Division. Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.
As the Sr Quality Engineer, you’ll have the chance to work closely with Manufacturing and Engineering on sustaining activities to ensure compliance with the quality system requirements and achievement of Key Performance Indicators (i.e. NCMR’s, MA’s, Yield, Cost Reduction projects, etc.) and owns/lead process/product validation activities Works closely with Research and Development and Regulatory Affairs personnel (internal or external) to obtained support on sustaining activities and during new product introduction to assure compliance with product and regulatory requirements. Owns Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.) and aud...
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