Quality R&D Lead - Dds&Ivd

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

Vantaggi offerti da questo lavoro

Healthcare coverage

Meal vouchers

Flexible benefits platform

Language training

Descrizione del lavoro

Stevanato Group cerca un Quality R&D Lead per guidare attività di qualità nei progetti di sviluppo DDS. Sarai punto di riferimento per design control, gestione rischi e conformità QMS, collaborando con team di sviluppo e produzione.

La figura richiede almeno 5-8 anni in contenuti QA/R&D nel settore medicale, conoscenza di ISO 13485 e IEC 62304/14971, e ottime capacità di comunicazione interculture. Ruolo basato a Milano.

Competenze

• 5-8 anni di esperienza in Quality Assurance R&D in dispositivi medici o prodotti combinati.
• Conoscenza approfondita di Design Control (ISO 13485, FDA 21 CFR 820) e rischi (ISO 14971).
• Capacità di redigere e rivedere Risk Management Files e DHF; familiarità con QMS e norme applicabili.
• Ottime doti comunicative e lavoro cross-funzionale.

Mansioni

• Interverrà come Quality Lead in progetti di sviluppo prodotto, guidando la progettazione e la trasferibilità in Operations, conformi al Design Control.
• Supporta il Team di Progettazione come riferimento quality e tecnico nelle decisioni chiave.
• Guiderà attività di qualità su sviluppo prodotto e processo, inclusi pianificazione, input/output, verifica, validazione e trasferimento.
• Revisione e approvazione della documentazione Design Control, DHF e deliverables di Risk Management.

Conoscenze

Quality Assurance

Design Control

Risk Management

Normative & Regulatory

Cross-functional collaboration

Descrizione del lavoro

Quality R&D Lead

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.

Scopra di più sulle mansioni generali e sulle competenze richieste per questa opportunità leggendo di seguito.

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 approprietness 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, Pharamceurical 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 authoring and reviewing Risk Management Files and Design History Files Familiarity with QMS and applicable standards and regulations. Strong communication skills and ability to work cross-functionally.

Preferred Qualifications

Experience with drug delivery systems, combination products, or complex medical devices. Experience integrating supplier risk assessments and external component risks into system-level risk evaluations. Knowledge of Human Factors Engineering (IEC 62366), software risk management (IEC 62304), and cybersecurity risk management. Experience participating in Notified Body and FDA inspections.

What We Offer

• Comprehensive health and protection coverage, including supplementary health insurance and life insurance
• Meal vouchers / canteen services, supporting your everyday experience at work
• Access to our welfare platform, with flexible benefits to support wellbeing, family needs, and lifestyle choices
• Continuous learning opportunities, including on-demand language training across a wide range of languages

For 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.

Our Commitment

At 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.