Junior Quality Engineer, Design Assurance

Location: Bussolengo

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 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.
What will your contribution be?
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 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 relation to risk analysis, design validation and applicable standards.

Cooperate with Regulatory Affairs Area to prepare regulatory submissions (e.g. 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:

Implement and update internal procedures relevant to the above mentioned activities.

Support the preparation and review of product technical & marketing sheets.

Contribute to the preparation of Instructions For Use for new or modified products.

Promote improvement initiatives, including the implementation of corrective and preventive action.

Support Customer Services and the Tender office by supplying product related declarations requested from customers or Authorities

Provide support during audits/inspections carried out by Notified Body or Regulatory Competent Authorities to achieve and maintain facility certifications.

What are we looking for?
Technical degree

1–2 years of experience in the medical device sector is preferred

Fluent English, both written and oral

Ability to work according to procedures, rules and regulations

Adherence to timelines and result oriented attitude

Knowledge of relevant regulations (European MDD, MDR, FDA Guidances, ISO 13485, ISO 14971, EN 62366, IEC 62304, IEC 6061, etc.).

Knowledge of relevant standards and application regarding biocompatibility, sterilization, reprocessing and cleaning.

Good knowledge and understanding of Microsoft Office Tools.

Travel 10-15% if needed

What soft skills will you improve?
Methodical and critical thinking.

Good organizational and project management skills.

Problem solving skills and proactivity

Precision and attention to detail

Ability to work in team and autonomously

Accountability for the assigned tasks

What will you find?
Friendly, warm, and…