Senior Design Assurance Quality Engineer

Orthofix; Bussolengo; Ibrido; EUR 40.000 - 43.000; Tempo pieno

Vantaggi offerti da questo lavoro

Canteen

Training and development

Smart working (two days per week)

Social events

Competitive compensation

International environment

Descrizione del lavoro

Orthofix, based in Bussolengo (VR), is hiring a Sr. Quality Engineer, Design Assurance to join the Quality Engineering team on a full‑time permanent contract.

You will liaise between Quality Compliance, QMS, R&D and Regulatory Affairs throughout product development and lifecycle, ensuring compliance with applicable standards and directives. You will lead Risk Management, usability validation, and regulatory release activities, while collaborating across departments to support post‑market

Competenze

• Must have a technical degree or master’s degree.
• 2–3 years experience in a similar role.
• Advanced knowledge of English and Italian.
• Knowledge of regulations (MDD, MDR, ISO 13485, ISO 14971, etc.) and biocompatibility, sterilization standards.

Mansioni

• Manage Risk Management activities during Product Development and post‑market surveillance.
• Coordinate usability and design validation with R&D, Marketing, Medical Science and Clinical Evidence.
• Coordinate regulatory release (CE Mark, FDA) for new products and modifications.
• Support PSUR, PMCF, CER activities related to risk analysis and design validation.
• Prepare regulatory submissions and Technical File documentation.

Conoscenze

English

Italian

Project management

Analytical thinking

Attention to detail

Team collaboration

Procedures compliance

Formazione

Master’s degree

Descrizione del lavoro

Orthofix, based in Bussolengo (VR), is hiring a Sr. Quality Engineer, Design Assurance to join the Quality Engineering team on a full‑time permanent contract.

You will liaise between Quality Compliance, QMS, R&D and Regulatory Affairs throughout product development and lifecycle, ensuring compliance with applicable standards and directives. You will lead Risk Management, usability validation, and regulatory release activities, while collaborating across departments to support post‑market