Quality R&D Lead — Medical Devices, Design Control & Risk

Stevanato Group

Spoleto

In loco

EUR 39.000 - 47.000

Tempo pieno

9 giorni fa

Generatore di candidature

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Vantaggi offerti da questo lavoro

Comprehensive health coverage

Meal vouchers

Welfare platform access

Language training

Descrizione del lavoro

Stevanato Group is seeking a Quality R&D Lead in Milan to act as the quality reference in product development, ensuring QMS and Design Control compliance. You will drive risk-based decisions throughout development, lead design reviews, and ensure proper risk management integration.

The role requires 5–8 years in QA/R&D within medical devices, strong knowledge of ISO 13485 and 21 CFR 820, and proven collaboration across teams.

Competenze

5-8 years of QA/R&D experience in Medical Device or combination product environments.
Strong knowledge of Design Control requirements (ISO 13485, FDA 21 CFR 820).
Solid experience with Risk Management (ISO 14971) and DHF auditing.
Familiar with QMS and regulatory standards in medical device development.
Excellent communication across functions and teams.

Mansioni

Act as Quality Lead in product development projects, ensuring design control compliance.
Support Design Team as quality and technical reference for key decisions.
Lead quality activities across product and process development including design transfer.
Review and approve Design Control documentation, DHF and Risk files.
Coordinate risk assessments and lifecycle changes with stakeholders.