Junior Quality Engineer, Design Assurance
Pubblicato il 23-08-2026 - Orthofix Holdings in Bussolengo
Role Overview
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.
Key Responsibilities
- Serve as the liaison between Quality Compliance, Quality Management System, R&D; and Regulatory Affairs during the Design & Development phase and throughout the product lifecycle, including post‑market surveillance and design changes.
- Manage and coordinate Risk Management activities during Product Development and post‑marketing surveillance.
- Coordinate and document usability and design validation activities, including participation in simulated use testing.
- Cooperate with internal departments to secure regulatory release (CE Mark, FDA approval) for new products and modifications.
- Support Quality Compliance and Clinical Evidence areas in Post‑Market Surveillance: complaints analysis, PSUR, PMCF report and CER related to risk analysis, design validation and applicable standards.
- Prepare regulatory submissions (e.g., 510(k) pre‑market notifications)
and support all regulatory pre‑ and post‑market activities; prepare Technical File documentation.
- Assist R&D; in formalizing product requirements definition and review, project development plan, develop gate documentation and design verification documentation.
- Implement and update internal procedures relevant to the above activities.
- Support preparation and review of product technical and marketing sheets; contribute to Instructions for Use for new or modified products.
- Promote improvement initiatives, including corrective and preventive action (CAPA).
- Support Customer Services and the Tender office with product‑related declarations requested by customers or authorities.
- Provide support during audits/inspections by Notified Bodies or Regulatory Competent Authorities to maintain facility certifications.
Qualifications
- Technical degree in engineering or related field.
- 1–2 years