Process Excellence Lead - Medical Diagnostics

Chez Roche, vous pouvez être vous-même et être apprécié pour les qualités uniques que vous apportez. Notre culture encourage l'expression personnelle, le dialogue ouvert et les connexions authentiques, où vous êtes valorisé, accepté et respecté pour ce que vous êtes, vous permettant de prospérer tant personnellement que professionnellement. Voici comment nous visons à prévenir, arrêter et guérir les maladies et à garantir à chacun l'accès aux soins de santé aujourd'hui et pour les générations à venir. Rejoignez Roche, où chaque voix compte.

La position

The Opportunity

As 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. Joining a growing innovation hub, you will work in a cross-functional environment to secure compliant execution while continuously optimizing process efficiency to meet evolving organizational needs.

Key Responsabilities

• Process Support: Provide process guidance and support for system, software, and assay projects with low complexity across Risk, Requirements, Configuration, Verification & Validation and Defect Management.

• Product Requirements: Support the creation and maintenance of product requirements by using the respective IT tool. Ensure that the appropriate documentation is created and are responsible for obtaining approval from the stakeholders.Facilitate and maintain the requirements traceability throughout the development of the product

• R isk Assessment: Support execution of product risk assessments. Create and maintain respective risk documentation.

• Configuration Management : Establish and maintain Configuration Management for projects, maintaining a clear overview of past, present, and future product configurations.

• Defect Management: Support with defect management by creating the defect management plan and managing defects.

• Verification & Validation: Provide support to ensure that V&V activities are planned, executed and documented according to our internal procedures.

• Continuous Improvement: Identify opportunities for process optimization and "radical simplification" to improve time-to-market without compromising quality

Who You Are

You are a proactive and service-oriented professional who excels at analytical thinking, problem-solving, and precise communication. You possess a collaborative mindset and are excited to grow your skills in a dynamic environment where we experiment and learn together.

To be successful in this role, you bring:

• Educational Foundation: A Bachelor’s degree in Engineering, Life Sciences, Natural Sciences, or a related field.

• Regulated Industry Expertise: A minimum of 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: Aunderstanding of Design Control processes and relevant global standards, such as ISO 13485 or IEC 62304.

• Digital Fluency: Familiarity with ALM tracking systems (such as Jira, Azure DevOps, RETINA, or HP ALM) is considered aplus.

• Exceptional Communication: Clear, precise, and efficient communication skills in English; knowledge of Spanish is a valuable asset.

There are 2 positions of this role.

At Roche, you’ll thrive in a culture that values different perspectives and creates a place of belonging, where we challenge ourselves to excel and achieve strong results, together.

Qui nous sommes

Un avenir plus sain nous pousse à innover. Ensemble, plus de 100 000 employés à travers le monde sont dédiés à faire progresser la science et à garantir à chacun l'accès aux soins de santé aujourd'hui et pour les générations à venir. Nos efforts aboutissent à plus de 26 millions de personnes traitées avec nos médicaments et plus de 30 milliards de tests réalisés avec nos produits de Diagnostique. Nous nous encourageons mutuellement à explorer de nouvelles possibilités, à favoriser la créativité et à conserver nos grandes ambitions, afin de fournir des solutions de santé qui changent des vies et ont un impact mondial.

Construisons ensemble un avenir plus sain.

Roche est un employeur offrant l'équité en matière d'emploi.