Product Surveillance Engineer I
Posted by CooperCompanies • La Garita, Provincia de Alajuela, Costa Rica
About the Role
The Product Surveillance Engineer is responsible for performing root cause analysis on clinically applied medical device and invitro fertilization (IVF) global customer returns to ensure high levels of quality, reliability, safety, and efficacy. In addition to, collaborating as needed with internal Quality, Service, Engineering, Manufacturing, and Research and Development (R&D) teams. While assisting management with continuous improvement and maintaining complaint handling processes and activities utilizing six sigma and lean processes. As well as, assisting management in maintaining compliance with global medical device regulations and safety standards.
Test and thoroughly evaluate clinically applied medical devices and IVF products of various degrees of complexity to determine root cause analysis within a closely monitored time frame.
Identifying the appropriate test method/regiment/tools from existing Standard Operating Procedures for complaint sample e...
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