Quality Engineer – Medical Devices

About the role

As a Quality Engineer within the Quality Assurance team at the Saluggia plant, you will support the development, manufacturing, release and post‑market surveillance of MicroPort CF medical devices. You will maintain quality KPIs, provide technical guidance, and drive continuous improvement to meet business goals.

Key responsibilities

• Manage product and process non‑conformities autonomously.
• Develop, review and approve quality system procedures.
• Lead root‑cause investigations and corrective actions (CAPA).
• Participate in internal and external audits and trend analysis.
• Lead or support cost‑reduction and compliance projects.
• Create and maintain device risk management throughout design.
• Collaborate on the development, validation and approval of test methods and process validation strategies.
• Drive continuous improvement of quality and design reviews.

Required profile

• Fluent in English and Italian with strong written and verbal communication.
• Degree in Biomedical, Mechanical or Electronic Engineering (Master preferred).
• Minimum 2 years experience in a medical‑device or GMP‑regulated environment.
• Good problem‑solving abilities and ability to teach technical topics.

Required skills

• Microsoft Word, PowerPoint, Excel and Outlook.
• Laboratory techniques, including destructive/non‑destructive analysis and microscope use.
• Risk‑management tools and statistical techniques.
• Calibration procedures.
• Knowledge of ISO 13485:2016, 21 CFR 820 and MDR.

What we offer

• Salary range: €33,000 – €38,000 per year.
• Permanent full‑time contract under the CCNL Industria Chimica.