Senior Process Manager
On-site · Sant Cugat del Vallès, Catalonia, Spain
Job Summary
Senior Process Manager in Design Control Excellence (DCE) leads requirement, risk, configuration, defect management and verification & validation within complex development projects. Provides expert guidance for complex system, software, and assay projects across risk, requirements, configuration, and defect management; supports multi-level requirements traceability within a streamlined, database-driven approach; conducts strategic risk assessments with cross-functional teams; builds and maintains configuration management to provide a clear view of past, present, and future product states. Ensures regulatory excellence by aligning V&V activities with internal standards and ISO 13485 and related requirements; identifies opportunities for radical simplification to improve time-to-market without compromising quality; collaborates globally in an agile, multicultural environment to deliver results for patients.
Required Qualifications
- Master’s degree in Engineering, Life Sciences, Natural Sciences, or a related field
- Minimum of three years of experience in a regulated environment within product development or process management (Medical Device or Diagnostics industry preferred)
- Strong understanding of Design Control processes and global standards such as ISO 13485 or IEC 62304
- Experience with ALM tools such as Jira, Azure DevOps, or specialized requirements management software is highly valued
- Exceptional communication skills in English
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