Process Manager - Design Control Excellence

About the role

Roche is hiring two Process Managers for its Design Control Excellence (DCE) team in Sant Cugat. You will help develop the processes that keep life-saving diagnostic products safe, effective and compliant, working in a cross-functional environment to optimise process efficiency.

Key responsibilities

• Support system, software and assay projects with low complexity across risk, requirements, configuration, verification and validation and defect management.
• Create and maintain product requirements in the relevant IT tool, obtain stakeholder approvals and maintain requirements traceability.
• Support product risk assessments and maintain risk documentation.
• Set up and maintain configuration management, keeping track of past, present and future product configurations.
• Create the defect management plan and manage defects.
• Ensure V&V activities are planned, executed and documented according to internal procedures.
• Identify opportunities for process improvement and radical simplification to speed time to market without compromising quality.

Required profile

• Bachelor's degree in Engineering, Life Sciences, Natural Sciences or a related field.
• At least three years of experience in a regulated product development environment (or a Master's degree).
• Preferred exposure to the medical device or diagnostics industry.
• Proactive, service-oriented, analytical and collaborative.
• Clear, precise English; Spanish is a valuable asset.

Required skills

• Understanding of design control processes and standards such as ISO 13485 or IEC 62304.
• Familiarity with ALM tools (Jira, Azure DevOps, RETINA, HP ALM) is a plus.