QA R&D Engineer

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 is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Summary: Covering this position, you’ll have the opportunity to execute Product Quality activities within New Product Development (NPD), Sustaining Engineering (SPO) and Regulatory Compliance projects for dialysis electromechanical devices, based on the project assignments received by the Product Quality Manager. You’ll also participate directly in projects for continuous improvement of product quality handling design NCR/CAPA (as quality approver) and Product Quality Data Review (PQDR) activities.

Key Responsibilities

• Be member of Project Core teams for New Product Development Projects and design Change Controls as Product Quality representative.
• Executes Product Quality activities within New Product Development (NPD), Sustaining Engineering (SPO) and Regulatory Compliance projects for dialysis electromechanical devices, based on the project assignments received by the Product Quality Manager.
• Review the documents for Device History File issuing and maintenance.
• Assure compliance to all applicable corporate procedures as well as all local work instructions and applicable laws and standards.
• Ensures that complaint data and CAPA corrective actions from current products are considered in sustaining engineering activities.
• Reviews and approves design NCR/CAPA for the product families assigned.
• Retrieves and analyzes Product Quality data in post market phase, in order to trend safety and performance of the devices in the field (PQDR).
• Cooperate and support other Company entities for Audits (internal and external) preparation.
• Periodically reporting to Product Quality Manager about the status of activities under his/her responsibility.

Qualifications & Experience

• Degree in Engineering (Biomedical field preferred) or scientific disciplines
• Previous experience in Med-Tech industry with focus on medical devices (R&D experience on electromechanical devices is preferred)
• Knowledge and experience of Quality System based on ISO 13485, FDA, CFR, GMP regulation and MDSAP
• Knowledge of Design Control and Risk Management principles is considered an advantage
• Critical thinking, problem-solving, collaboration, communications skills are required
• English Knowledge

At Vantive, we are committed to fair and transparent pay practices and to creating an environment where people feel valued and supported. We know that compensation matters when considering a new role.

The minimum annual base salary for this position is 38.400Euro. Your starting salary may be higher, depending on factors such as your skills, experience, qualifications, and the unique perspective you would bring to the role. Employment for this position is governed by the Italian Chemical and Pharmaceutical National Collective Labor Agreement (CCNL Chimico-Farmaceutico).

We carefully consider each candidate individually while also ensuring fairness and consistency across our organization.

In addition to base pay, this position may be eligible for a competitive benefits package designed to support your well-being, professional growth, and life beyond work.

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally.

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