We are looking for a Quality R&D; Lead to join our Quality R&D; team in Milan, supporting our Drug Delivery Systems (DDS) Business Unit.

Key accountabilities

- Act as Quality Lead in product development projects, ensuring design development and transfer to Operations follow Design Control principles.
- Support the Design Team as quality and technical reference in key decisions.
- Lead quality activities across product and process development, including design planning, inputs, outputs, verification, validation, and design transfer.
- Review and approve Design Control documentation, DHF and Risk Management deliverables.
- Act as Process Owner for Design & Development procedures, templates and tools.
- Ensure correct application of procedures through training and continuous support to R&D; teams.
- Ensure risk management is fully integrated into Design Control processes, from user needs and design inputs through verification, validation, transfer, and post-market activities.
- Lead change impact and risk assessments, supporting change approval and lifecycle change control.
- Coordinate, Review and approve Risk Management File deliverables.
- Collaborate with internal and external stakeholders to promote a strong and modern quality mindset.

Qualifications

- 5-8 years' experience in Quality Assurance R&D; within Medical Device, Combination Product, Pharamceurical environments.
- Strong knowledge of Design Control requirements (ISO 13485, FDA 21 CFR 820 / QMSR).
- Strong knowledge and practical application of ISO 14971 Risk Management principles and methodologies.




- Experience authoring and reviewing Risk Management Files and Design History Files
- Familiarity with QMS and applicable standards and regulations.
- Strong communication skills and ability to work cross-functionally.

Preferred Qualifications

- Experience with drug delivery systems, combination products, or complex medical devices.
- Experience integrating supplier risk assessments and external component risks into system-level risk evaluations.
- Knowledge of Human Factors Engineering (IEC 62366), software risk management (IEC 62304), and cybersecurity risk management.
- Experience participating in Notified Body and FDA inspections.

What We Offer

- Comprehensive health and protection coverage, including supplementary health insurance and life insurance
- Meal vouchers / canteen services, supporting your everyday experience at work
- Access to our welfare platform, with flexible benefits to support wellbeing, family needs, and lifestyle choices
- Continuous learning opportunities, including on-demand language training across a wide range of languages

For this role, the expected compensation range starts from € 43.000. The actual compensation will depend on a variety of job-related factors, including geographic location, professional experience, education, and skill level.

Our Commitment

At Stevanato Group, we are committed to building a diverse and inclusive workplace, and we believe that potential, mindset, and motivation matter just as much as experience.

Quality R&D; Lead - DDS&IVD; Lombardy, Italy

📌 Quality R&D Lead - Dds&Ivd (Bardi)
🏢 STEVANATO GROUP
📍 Bardi