Quality R&D Lead

01 ott - Bardi
STEVANATO GROUP

ppWe are looking for a bQuality RD Lead /b to join our Quality RD team in Milan, supporting our Drug Delivery Systems (DDS) Business Unit. /p pIn this role, you will act as the Quality reference within product development projects, ensuring compliance with the Quality Management System (QMS) and applicable standards, leading design reviews and approving key design control deliverables. /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 liLead change impact and risk assessments, supporting change approval and lifecycle change control. /li liReview 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 li4-7 years' experience in Quality Assurance RD within Medical Device / Pharma / regulated environments. /li liStrong knowledge of Design Control, Change Control and Risk Management. /li liFamiliarity with QMS and applicable standards and regulations. /li liStrong communication skills and ability to work cross-functionally. /li /ul /p #J-*****-Ljbffr

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