Quality R&D Lead - DDS&IVD
Pubblicato il 05-09-2026 - STEVANATO GROUP in Varese
pWe are looking for a bQuality RD Lead /b to join our Quality RD team in Milan, supporting our Drug Delivery Systems (DDS) Business Unit. /ppbr/ppIn 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/ppbKey accountabilities /b /pulliAct as Quality Lead in product development projects, ensuring design development and transfer to Operations follow Design Control principles. /liliSupport the Design Team as quality and technical reference in key decisions. /liliLead quality activities across product and process development, including design planning, inputs, outputs, verification, validation, and design transfer. /liliReview and approve Design Control documentation, DHF and Risk Management deliverables. /liliAct as Process Owner for Design Development procedures, templates and tools. /liliEnsure correct application of procedures through training and continuous support to RD teams. /liliEnsure risk management is fully integrated into Design Control processes, from user needs and design inputs through verification, validation, transfer, and post-market activities. /liliLead change impact and risk assessments, supporting change approval and lifecycle change control. /liliCoordinate, Review and approve Risk Management File deliverables. /liliCollaborate with internal and external stakeholders to promote a strong and modern quality mindset. /li /ulpbr/ppbQualifications /b /pulli5-8 years’ experience in Quality Assurance RD within Medical Device, Combination Product, Pharamceurical environments. /liliStrong knowledge of Design Control requirements (ISO 13485, FDA 21 CFR 820 / QMSR).
/liliStrong knowledge and practical application of ISO 14971 Risk Management principles and methodologies. /liliExperience authoring and reviewing Risk Management Files and Design History Files /liliFamiliarity with QMS and applicable standards and regulations. /liliStrong communication skills and ability to work cross-functionally. /li /ulpbr/ppbPreferred Qualifications /b /pulliExperience with drug delivery systems, combination products, or complex medical devices. /liliExperience integrating supplier risk assessments and external component risks into system-level risk evaluations. /liliKnowledge of Human Factors Engineering (IEC 62366), software risk management (IEC 62304), and cybersecurity risk management. /liliExperience participating in Notified Body and FDA inspections. /li /ulpbr/ppbWhat We Offer /b /ppAt 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 vantaggi 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 /ppFor 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/ppbOur Commitment /b /ppIf this opportunity resonates with you, we encourage you to explore it further and apply even if your experience doesn’t perfectly match every requirement. /ppAt Stevanato Group, we are committed to building a diverse and inclusive workplace, and we believe that bpotential, mindset, and motivation matter just as much as experience. /b /p