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.

Responsabilidades

- Provide 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 principales

- Bachelor’s degree in Engineering, Life Sciences, Natural Sciences, or related field
- Minimum of three years in a regulated product development environment (or a Master’s degree); medical device or diagnostics exposure preferred
- Understanding of Design Control processes and integral standards (ISO 13485, IEC 62304)
- Digital fluency with ALM tracking systems (Jira, Azure DevOps, RETINA, HP ALM) is a plus
- Excellent English communication; Spanish knowledge is an asset

- Proactive
- Service-oriented
- Analytical thinking
- Design Control processes
- Risk management
- Configuration management

📌 Process Manager (San Cugat del Vallés)
🏢 Roche
📍 San Cugat del Vallés