Junior Quality Engineer, Design Assurance

20 ago - Italia
Altro

At Orthofix, we want team members who build relationships and share knowledge, challenge the status quo, and deliver results every day to help us achieve our vision to be the unrivaled partner in Med Tech.
Our global team of over 1,600 employees brings to market highly innovative, cost-effective, and user-friendly medical technologies that heal musculoskeletal pathologies for patients and the healthcare professionals who treat them. We offer an interesting opportunity to join our Quality Engineering team, based in Bussolengo (VR) as Junior Quality Engineer, Design Assurance reporting to the Quality Engineering Manager.
Yo will be the liaison between Quality Compliance, Quality Management System, Research & Development (R&D;) Area and Regulatory Affairs Area during the Design & Development phase of products and their complete lifecycle, including post market surveillance and design changes.
You must guarantee that Design & Development activities are conducted in compliance with internal procedures and in conformity with standards, directives and laws applicable to the Organization.




You will work strictly in contact with Design & Development Area coordinating specific activities like Risk Management process, design validation, usability and final release.
E. promote, coordinate and document) the Risk Management activities during the Product Development Process, in relation to product modifications and during post-marketing surveillance.
Manage (promote, coordinate and document), in cooperation with R&D;, Marketing, Medical Science and Clinical Evidence, the usability and design validation about new products, including partecipation to simulated use testing activities.
Cooperate with internal departments during the Product Development Process to the regulatory release (CE Mark, FDA approval) for:
Support Quality Compliance and Clinical evidence areas in the Post-Market Surveillance activities providing contribution to complaints analysis, PSUR, PMCF report and CER in rel

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