Quality R&D Lead

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7gd804

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.
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 appropriateness of key design control and risk management deliverables.
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, Pharmaceutical 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 auth

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7gd804