Descripción de la oferta
Overview
In this Process Manager role within Roche’s Design Control Excellence team in Sant Cugat, you enable safe, effective, compliant diagnostic products by overseeing essential development processes. You’ll drive requirements, risk, configuration, verification & validation, and defect management across development projects in a cross-functional setting. The role combines process optimization with a hands-on approach to documentation and governance, contributing to faster, compliant time-to-market. You’ll work in a growth-focused hub where collaboration and continuous improvement matter.
ResponsabilidadesProvide process guidance for system, software, and assay projects across Risk, Requirements, Configuration, Verification & Validation, and Defect Management.Support creation and maintenance of product requirements using the designated IT tool; secure stakeholder approvals and maintain traceability.Assist in conducting product risk assessments and maintaining risk documentation.Establish and maintain Configuration Management to keep a clear view of product configurations.Support defect management by drafting the defect management plan and tracking defects.Ensure V&V activities are planned, executed, and documented per internal procedures.Identify opportunities for process optimization and radical simplification to shorten time-to-market while preserving quality.
Requisitos principalesBachelor’s degree in Engineering, Life Sciences, Natural Sciences, or related fieldMinimum of three years in a regulated product development environment (or a Master’s degree); medical device or diagnostics exposure preferredUnderstanding of Design Control processes and global standards (ISO 13485, IEC 62304)Digital fluency with ALM tracking systems (Jira, Azure DevOps, RETINA, HP ALM) is a plusExcellent English communication; Spanish knowledge is an assetProactiveService-orientedAnalytical thinkingDesign Control processesRisk managementConfiguration management
