Junior Quality Engineer, Design Assurance

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7czj34

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.
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; Assist R&D; in formalizing product requirements definition and review, project development plan, develop gate documentation and design verification documentation.
Provide support during audits/inspections by Notified Bodies or Regulatory Competent Authorities to maintain facility certifications.
Technical degree in engineering or related field.
~1–2 years of experience in the medical device sector (preferred).
~ Fluent in English, written and oral.
~ Proficiency in Microsoft Office tools.
~ Willingness to travel 10–15% if needed.

Good organizational and project‑management skills.
Training and development opportunities.
Lavoro da remoto model (two days per week).
Social and company events.
Benefits: Pension Fund, Health Insurance.
Full‑time job. Working hours: 8:30–17:30 Monday–Thursday, 8:30–16:30 Friday.
Contract: maternity substitution.

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7czj34