Design Quality Engineer

<b>Title: Design Quality Engineer</b><br /> <b>Location: Plano, TX (onsite)</b><br /> <b> </b><br /> <b>Job Description:</b> <ul> <li>6+ years of Medical devices - Design Quality experience for the projects related to Design Change, Clinical and New Product Development. </li> <li>Good experience in Medical devices regulations ISO13485, FDA & EU MDR regulations</li> <li>Experience in compiling Design history files & Technical file submission for 510k & CE mark</li> <li>Own Risk Management files Risk management plan, Hazard Analysis, DFMEA, UFMEA, Risk Management report</li> <li>Work with cross functional teams to execute and/or support various areas of Design Control processes, such as Design Input requirements, Design Outputs, Design Verification and Design Validation.</li> <li>Review & approve all the design history files wi...