Your mission:
Indivi is a TechBio company enabling precision and personalised medicine to become a reality in neuroscience research and development. We are going through significant growth and looking for new team members who want to contribute to making our vision — _making measurable what is not so_ — a reality.

Your profile:
As a Quality Process Analyst, you will play a key role in ensuring that our software products in the Digital Health / SaMD space are developed, maintained, and released in full compliance with applicable regulatory and quality requirements.

Responsibilities

Quality Management / Compliance / Product Lifecycle Oversight:
- Collaborate with cross-functional teams to identify and mitigate product and regulatory risks throughout the product lifecycle.- Build and maintain collaboration between the product team, the development teams and quality team.- Support the establishment of product technical dossiers.- Review and approve documents and records to ensure QMS compliance,



product quality and safety.- Delegation of complaint manager.- Lead product change management process to ensure changes are assessed according to their impact, correct documents are included and approver and change team are identified.- Conduct internal audits to ensure compliance with applicable procedures and standards.- Develop and maintain QMS related processes and documentation.- Develop and deliver training to employees, if applicable.- Participate in the development or maintenance of products and ensure compliance requirements are incorporated into the design and development process.- Support product risk assessments and risk mitigation strategies as well as validation strategies.- Support the supplier evaluation and qualification.- Support the development and maintenance of product technical dossiers.- Analyze trends in complaints and nonconformances to identify systemic issues and drive improvement.

Necessary Competence (Education / Qualification):
- A University de

📌 Quality Process Analyst (Córdoba)
🏢 Indivi
📍 Córdoba