QA R&D Engineer, Med-Tech Quality & NPD

Vantive; Medolla; On-site; EUR 35,000 - 42,000; Full time

Job summary

Vantive in Medolla, Italy seeks a Product Quality professional to drive QA across NPD, SPO and regulatory projects for dialysis electromechanical devices. You will act as quality approver for NCR/CAPA and PQDR activities, and support audits.

Requirements include a Biomedical Engineering degree, Med-Tech experience with ISO 13485/FDA knowledge, strong problem‑solving and collaboration, and fluent English. Base pay starts at 38,400 EUR/year under CCNL Chimico-Farmaceutico.

Qualifications

• Degree in Engineering (Biomed) or scientific field.
• Experience in Med-Tech devices preferred; R&D on electromechanical devices is a plus.
• Knowledge of ISO 13485, FDA CFR GMP and MDSAP is required or advantageous.

Responsibilities

• Be member of Project Core teams for NPD and design Change Controls as Product Quality representative.
• Execute Product Quality activities in NPD, SPO and Regulatory projects for dialysis devices.
• Review documents for Device History File issuance and maintenance.
• Ensure compliance with corporate procedures, local work instructions, and standards.
• Incorporate complaint data and CAPA actions into sustaining engineering activities.
• Review and approve NCR/CAPA for product families.
• Retrieve and analyze PQ data post‑market to trend device safety and performance.
• Support internal and external audits and report status to Product Quality Manager.

Skills

Critical thinking

Problem solving

Collaboration

Communication skills

English

Education

Engineering (Biomedical) degree

Job description

Vantive in Medolla, Italy seeks a Product Quality professional to drive QA across NPD, SPO and regulatory projects for dialysis electromechanical devices. You will act as quality approver for NCR/CAPA and PQDR activities, and support audits.

Requirements include a Biomedical Engineering degree, Med-Tech experience with ISO 13485/FDA knowledge, strong problem‑solving and collaboration, and fluent English. Base pay starts at 38,400 EUR/year under CCNL Chimico-Farmaceutico.