Junior Quality Engineer, Design Assurance

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7dabov

Role OverviewWe 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.

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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 Auth

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7dabov