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Quality Process Analyst

Córdoba, Spain
Full-time
Permanent employee

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 degree in Computer Science, Engineering, or a related technical field is preferred. Other degrees or relevant qualifications might be considered.

  • Previous experience in software development.

  • Minimum of 2 years of previous experience in the SaMD or Digital Health industry or similar. 

  • Previous experience in participating in the development of new products and ensuring regulatory requirements are incorporated into the design and development process.

  • Basic understanding of ISO 13485 and privacy regulations.

  • Ability to deliver high-quality documentation, paying attention to detail.

  • Excellent written and verbal communication skills.

  • Strong problem-solving skills

  • Able to prioritize tasks and meet deadlines.

  • Ability to adapt to changing regulatory requirements and industry trends.


Needed skills or mandatory training:

  • Certification in a relevant area is a plus.

  • English proficiency is essential (minimum B2). Knowledge of Spanish is advantageous.

About us

We are looking for highly motivated and experienced people with our like-minded focus on improving the lives of people with neurological disease.  

Indivi is an equal opportunities employer and encourages applications from candidates of all backgrounds, particularly those from underrepresented groups. Reasonable adjustments will be made wherever possible.
 
https://indivi.io