QA R&D Engineer (Medical Devices)

Location: Medolla, Modena, Italy

Minimum annual base salary: €38,400

Company

hirify.global develops vital organ therapy solutions, including dialysis devices, digital solutions, and advanced services intended to improve outcomes for patients and care teams.

What you will do

• Execute Product Quality activities across New Product Development, Sustaining Engineering, and Regulatory Compliance projects for dialysis electromechanical devices.
• Participate in project core teams and design change controls as the Product Quality representative.
• Review Device History File documentation and support its issuing and maintenance.
• Review and approve design NCR/CAPA activities and ensure complaint data and corrective actions are considered in sustaining engineering.
• Retrieve and analyze post-market Product Quality data to identify safety and performance trends through PQDR activities.
• Support internal and external audit preparation and report activity status to the Product Quality Manager.

Requirements

• Degree in Engineering, preferably Biomedical Engineering, or in a scientific discipline.
• Previous MedTech industry experience focused on medical devices; R&D experience with electromechanical devices is preferred.
• Knowledge and experience with Quality Systems based on ISO 13485, FDA, CFR, GMP regulations, and MDSAP.
• Critical thinking, problem-solving, collaboration, and communication skills.
• English knowledge is required.

Nice to have

• Knowledge of Design Control and Risk Management principles.
• R&D experience with electromechanical medical devices.

Culture & Benefits

• Full-time employment governed by the Italian Chemical and Pharmaceutical National Collective Labor Agreement (CCNL Chimico-Farmaceutico).
• Base salary may exceed €38,400 annually depending on skills, experience, qualifications, and individual contribution.
• Eligibility for a competitive benefits package supporting well-being, professional growth, and life beyond work.
• Reasonable accommodations are available for candidates with disabilities during the application and interview process.