Quality R&D Lead

Experteer Overview

In this role you will lead Quality R&D activities within the Drug Delivery Systems domain to ensure QMS compliance and design control discipline. You will act as the quality reference in product development projects, overseeing design reviews and key deliverables, and driving transfer to operations. You will shape quality decisions across design and process development, promoting a modern quality mindset across R&D and external partners. This is a hands‑on, cross‑functional role that links development, risk management, and lifecycle change control to enable compliant, efficient product delivery.

Benefits

• Act as Quality Lead in product development projects, ensuring design development and transfer 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.

Responsibilities

• 4‑7 years’ experience in Quality Assurance R&D within Medical Device / Pharma / regulated environments.
• Strong knowledge of Design Control, Change Control and Risk Management.
• Familiarity with QMS and applicable standards and regulations.
• Strong communication skills and ability to work cross‑functionally.