Quality R&D Lead - DDS&IVD

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7905hp

pWe are looking for a strong

Quality RD Lead /strong to join our Quality RD team in Milan, supporting our Drug Delivery Systems (DDS) Business Unit. /ppbr/pp

In this role, you will act as the Quality reference within product development projects, ensuring compliance with the Quality Management System (QMS), Design Control and Risk Management principles and applicable standards and regulations.

You will lead design reviews, drive risk-based decision making throughout the development lifecycle, guaranteeing the approprietness of key design control and risk management deliverables. /ppbr/ppstrong

Key accountabilities /strong /pulli

Act as Quality Lead in product development projects, ensuring design development and transfer to Operations follow Design Control principles. /lili

Support the Design Team as quality and technical reference in key decisions. /lili

Lead quality activities across product and process development, including design planning, inputs, outputs, verification, validation, and design transfer. /lili

Review and approve Design Control documentation, DHF and Risk Management deliverables. /lili

Act as Process Owner for Design Development procedures, templates and tools. /lili

Ensure correct application of procedures through training and continuous support to RD teams. /lili

Ensure risk management is fully integrated into Design Control processes, from user needs and design inputs through verification, validation, transfer, and post-market activities. /lili

Lead change impact and risk assessments,



supporting change approval and lifecycle change control. /lili

Coordinate, Review and approve Risk Management File deliverables. /lili

Collaborate with internal and external stakeholders to promote a strong and modern quality mindset. /li /ulpbr/ppstrong

Qualifications /strong /pulli5-8 years’ experience in Quality Assurance RD within Medical Device, Combination Product, Pharamceurical environments. /lili

Strong knowledge of Design Control requirements (ISO 13485, FDA 21 CFR 820 / QMSR). /lili

Strong knowledge and practical application of ISO 14971 Risk Management principles and methodologies. /lili

Experience authoring and reviewing Risk Management Files and Design History Files /lili

Familiarity with QMS and applicable standards and regulations. /lili

Strong communication skills and ability to work cross-functionally. /li /ulpbr/ppstrong

Preferred Qualifications /strong /pulli

Experience with drug delivery systems, combination products, or complex medical devices. /lili

Experience integrating supplier risk assessments and external component risks into system-level risk evaluations. /lili

Knowledge of Human Factors Engineering (IEC 62366),



software risk management (IEC 62304), and cybersecurity risk management. /lili

Experience participating in Notified Body and FDA inspections. /li /ulpbr/ppstrong

What We Offer /strong /pp

At Stevanato Group, we believe that great performance is sustained over time through the right combination of tools, support, wellbeing, and continuous development.

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

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. /ppbr/ppstrong

Our Commitment /strong /pp

If this opportunity resonates with you, we encourage you to explore it further and apply even if your experience doesn’t perfectly match every requirement. /pp

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

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7905hp