ppWe are looking for a Quality RD Lead to join our Quality RD team in Milan, supporting our Drug Delivery Systems (DDS) Business Unit. /p h3Key accountabilities /h3 ul liAct as Quality Lead in product development projects, ensuring design development and transfer to Operations follow Design Control principles. /li liSupport the Design Team as quality and technical reference in key decisions. /li liLead quality activities across product and process development, including design planning, inputs, outputs, verification, validation, and design transfer. /li liReview and approve Design Control documentation, DHF and Risk Management deliverables. /li liAct as Process Owner for Design Development procedures, templates and tools. /li liEnsure correct application of procedures through training and continuous support to RD teams. /li liEnsure risk management is fully integrated into Design Control processes, from user needs and design inputs through verification, validation, transfer, and post-market activities. /li liLead change impact and risk assessments, supporting change approval and lifecycle change control. /li liCoordinate, Review and approve Risk Management File deliverables. /li liCollaborate with internal and external stakeholders to promote a strong and modern quality mindset. /li /ul h3Qualifications /h3 ul li5-8 years' experience in Quality Assurance RD within Medical Device, Combination Product, Pharamceurical environments. /li liStrong knowledge of Design Control requirements (ISO 13485, FDA 21 CFR 820 / QMSR). /li liStrong knowledge and practical application of ISO 14971 Risk Management principles and methodologies.



/li liExperience authoring and reviewing Risk Management Files and Design History Files /li liFamiliarity with QMS and applicable standards and regulations. /li liStrong communication skills and ability to work cross-functionally. /li /ul h3Preferred Qualifications /h3 ul liExperience with drug delivery systems, combination products, or complex medical devices. /li liExperience integrating supplier risk assessments and external component risks into system-level risk evaluations. /li liKnowledge of Human Factors Engineering (IEC 62366), software risk management (IEC 62304), and cybersecurity risk management. /li liExperience participating in Notified Body and FDA inspections. /li /ul h3What We Offer /h3 ul liComprehensive health and protection coverage, including supplementary health insurance and life insurance /li liMeal vouchers / canteen services, supporting your everyday experience at work /li liAccess to our welfare platform, with flexible benefits to support wellbeing, family needs, and lifestyle choices /li liContinuous learning opportunities, including on-demand language training across a wide range of languages /li /ul pFor 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. /p h3Our Commitment /h3 pAt 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. /p pQuality RD Lead - DDSIVD Lombardy, Italy /p /p #J-18808-Ljbffr

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