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 Sr. Quality Engineer, Design Assurance, reporting to the Quality Engineering Manager , on a maternity substitution contract.
Manage (i.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 regulatory release (CE Mark, FDA approval) for: new products (standard products, small series, custom products); product modifications.
Support Quality Compliance and Clinical evidence areas in the Post-Market Surveillance activities providing contribution to complaints analysis, PSUR, PMCF report and CER in relation to risk analysis, design validation and applicable standards.
510K pre-market notifications), support all the regulatory pre- and post-market activities related to technical aspects and prepare the Technical File documentation; Support the R&D; Area to formalize: Product requirements definition and review; Project development plan; Design verification documentation.
Support the preparation and review of product technical & marketing sheets.
Preferred technical degree or master's degree.
A previous experie

Sr. Quality Engineer, Design Assurance

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