Quality R&D Lead - DDS & IVD Design Control Leader

Stevanato Group; Milano; In loco; EUR 39.000 - 47.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

Meal vouchers

Welfare platform

Continual learning

Descrizione del lavoro

Stevanato Group in Milan seeks a Quality R&D Lead to guide quality activities in product development for Drug Delivery Systems. You will own Design Control, risk management, and regulatory compliance across the design lifecycle, ensuring robust documentation and successful design transfer to operations.

Leading risk assessments and change control, you will work with multi-disciplinary teams and ensure ongoing QMS alignment and readiness for audits and inspections.

Competenze

• 5-8 years’ experience in Quality Assurance R&D within Medical Device, Combination Product.
• Strong knowledge of Design Control requirements (ISO 13485, FDA 21 CFR 820 / QMSR).
• Strong knowledge and practical application of ISO 14971 Risk Management principles.

Mansioni

• Act as Quality Lead in product development projects, ensuring design development and transfer to Operations follow Design Control principles.
• Review and approve Design Control documentation, DHF and Risk Management deliverables.
• Lead change impact and risk assessments, supporting change approval and lifecycle change control.
• Collaborate with internal and external stakeholders to promote a strong and modern quality mindset.

Conoscenze

Quality Assurance

Design Control

Risk Management

Regulatory Knowledge

Descrizione del lavoro

Stevanato Group in Milan seeks a Quality R&D Lead to guide quality activities in product development for Drug Delivery Systems. You will own Design Control, risk management, and regulatory compliance across the design lifecycle, ensuring robust documentation and successful design transfer to operations.

Leading risk assessments and change control, you will work with multi-disciplinary teams and ensure ongoing QMS alignment and readiness for audits and inspections.