Quality R&D Lead (12673)

Stevanato Group; Milano; On-site; EUR 50,000 - 70,000; Full time

Job summary

Stevanato Group is seeking a Quality R&D Lead to support its Drug Delivery Systems Business Unit in Milan. This role involves acting as the Quality reference within product development, ensuring compliance with the Quality Management System and relevant standards.

The Quality R&D Lead is responsible for leading design reviews, approving key deliverables, and ensuring that processes follow established design control principles. This is a great opportunity to join a dynamic organization that values talent and encourages professional growth.

Qualifications

• Experience in quality assurance and quality control within the medical device or pharmaceutical industry.
• Strong understanding of Quality Management Systems (QMS) and applicable standards.
• Ability to lead design reviews and understand design control processes.

Responsibilities

• Act as Quality Lead in product development projects, ensuring design development follows Design Control principles.
• Lead quality activities across product and process development.
• Review and approve Design Control documentation and Risk Management deliverables.

Job description

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) and applicable standards, leading design reviews and approving key design control 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.
• Lead change impact and risk assessments, supporting change approval and lifecycle change control.
• Review and approve Risk Management File deliverables.
• Collaborate with internal and external stakeholders to promote a strong and modern quality mindset.

We are a dynamic organization with great customers and a culture where people are valued and empowered to deliver amazing results. We are also growing and looking to hire talented and passionate individuals to join our team!