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 experience of 2/3 years in a similar role is required, preferably in a regulated industry (medical device). Advanced knowledge of English and Italian. Excellent organizational and project management skills. Knowledge of relevant regulations (European MDD, MDR, FDA Guidances, ISO 13485, ISO 14971, EN 62366, IEC 62304, IEC 6061, etc.). Good interpersonal skills and ability to work in cross-functional teams. Friendly, warm, and innovative atmosphere. Healthy, inspiring, and international and inclusive work environment. Training and development opportunities. Lavoro da remoto model (two days per week). Wellbeing initiatives (welfare).

Canteen

Benefits (Pension Fund- Health Insurance).

Working Hours: 8:30-17:30 Monday to Thursday and 8:30-16:30 Friday.

Contract type: full-time, maternity substitution contract.

Salary package range: 40.000/43.000 euro* (The package will be evaluated based on the experience of the person). This is a full-time job. The contract is a maternity substitution contract. #

📌 Sr. Quality Engineer, Design Assurance (Verona)
🏢 Orthofix Holdings
📍 Verona