Junior Quality System Engineer

21 ago - Italia
Orthofix

Why Orthofix?
Guided by our organizational values – Take Ownership | Innovate Boldly | Win Together – we collaborate closely with world-class surgeons and other partners to improve people’s quality of life. 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. Looking to change people’s lives? Look no further.
We offer an interesting opportunity to join our Quality Compliance team, based in Bussolengo (VR) as Junior Quality Complaints Engineer , reporting to the Quality Complaints Supervisor, on a full-time temporary contract.
As part of the Quality Team, you will be responsible for the effective management of post-market surveillance activities, with a primary focus on the intake, documentation,



evaluation, and investigation of product complaints related to limb reconstruction medical devices.
You will This role ensures that all complaints are accurately recorded, assessed, and processed in compliance with applicable regulatory requirements, including MDR, FDA, and global vigilance regulations.
What will your contribution be?
Complaint Handling: record and manage complaints in the quality system, ensuring all information is complete and traceable.
Technical Evaluation: investigate complaints to identify device issues, possible failures, and root causes, working with relevant teams when needed.
Vigilance Reporting: assess whether events are reportable under regulations (e.g., EU MDR, FDA) and submit reports within required timelines.
Signal Detection: review complaint data to identify recurring issues/trends or potential risks.
Regulatory Compliance: ensure all complaint activities follow i

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