Sr. Quality Engineer, Design Assurance

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 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 Sr. Quality Engineer, Design Assurance , reporting to the Quality Engineering Manager , on a full time contract.

As part of the Quality Team, you will be responsible for liasing 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 will 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 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 ( 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.

Cooperate with Regulatory Affairs Area to prepare regulatory submissions ( 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;

Produce development phase gate documentation;

Design verification documentation.

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

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

Travel may be needed (10%-15%)

What are we looking for?

Preferred technical degree or master’s degree.

A previous experience of at least 3 years in a similar role is required, preferably in a regulated industry (medical device).

Advanced knowledge of English and Italian

Methodical and critical thinking.

Excellent organizational and project management skills.

Problem solving skills and proactivity

Ability to work according to procedures, rules and regulations

Adherence to timelines and result oriented attitude

Precision and attention to detail

Analytical approach to resolve complex issues

Ability to work in team and autonomously

Accountability for the assigned tasks

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.

What soft skills will you improve?

Ability to work precisely according to procedures, rules, and regulations

Analytical mindset, attention to detail, and ability to manage multiple priorities.

Good interpersonal skills and ability to work in cross-functional teams.

Adherence to timelines and result result-oriented attitude

Orderliness and atte