Descripción de la oferta
Position & OpportunityAs a Process Manager within our Design Control Excellence (DCE) team in Sant Cugat, you will be responsible for the essential development processes that ensure our life‑saving diagnostic products are safe, effective, and compliant. You will play a key role in the execution of Requirement Management, Product Risk Management, Configuration Management, Defect Management, and Verification & Validation within development projects.Key Responsibilities- Process Support: Provide guidance and support for low‑complexity system, software, and assay projects with Risk, Requirements, Configuration, Verification & Validation, and Defect Management.- Product Requirements: Support creation and maintenance of product requirements using the appropriate IT tool, ensuring documentation is produced and approved by stakeholders.- Risk Assessment: Support execution of product risk assessments and maintain corresponding risk documentation.- Configuration Management: Establish and maintain configuration management for projects, keeping a clear overview of product configurations.- Defect Management: Develop the defect management plan and manage defects throughout the product lifecycle.- Verification & Validation: Ensure V&V activities are planned, executed, and documented according to internal procedures.- Continuous Improvement: Identify opportunities for process optimization and simplification to improve time‑to‑market without compromising quality.Qualifications- Educational Foundation: Bachelor’s degree in Engineering, Life Sciences, Natural Sciences, or a related field.- Regulated Industry Expertise: Minimum three years of professional experience in a regulated product development environment (or a Master’s degree), with preferred exposure to the Medical Device or Diagnostics industry.- Technical Process Mastery: Understanding of Design Control processes and relevant global standards such as ISO13485 or IEC62304.- Digital Fluency: Familiarity with ALM tracking systems (e.G., Jira, Azure DevOps, RETINA, or HPALM) is considered a plus.- Exceptional Communication: Clear, precise, and efficient communication skills in English; knowledge of Spanish isa valuable asset.- Additional Information: Two positions are available for this role.Equal Opportunity StatementRoche is an Equal Opportunity Employer. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world.#J-18808-Ljbffr
