Quality Systems Analyst

About Us

Idoven has developed the world’s first cardiology-as-a-service platform powered by artificial intelligence that augments both a cardiologist’s and non-cardiology expert clinician’s ability to identify, triage and diagnose patients at scale.

The company counts partners such as AstraZeneca, Abbott, and GE Healthcare, FIFPRO, Google, Santander and Real Madrid Foundation. Idoven is backed by top-tier investors and business angels including Insight Partners, Northzone and Wayra (Telefónica), Iker Casillas, Pau Gasol, the Accel Starters program, and EIT Health.

The company has been awarded with numerous distinctions for its AI technology in Europe and the US, including the prestigious European Innovation Council (EIC) Accelerator and Horizon 2020 (H2020) awards and the Healthy Longevity Catalyst Award from the US National Academy of Medicine. Idoven has also been selected by CB Insights as one of the top 50 companies in Digital Health for 2023.

Responsibilities

• Quality Management System (QMS):

• Assist the Head of Quality in maintaining Idoven’s QMS to ensure compliance with applicable standards, included but not limited to ISO 13485, IEC 62304, ISO 82304, ISO 14971, and ISO/TR 24971.
• Stay informed of evolving quality and regulatory trends to drive continuous compliance.

• Customer Feedback & Complaints:

• Support the processing of customer feedback and complaints, ensuring timely and compliant responses.

• Supplier Quality Management:

• Manage supplier evaluations and re-evaluations to ensure compliance with quality standards.

• Audit Readiness & Compliance:

• Assist in ensuring the audit-readiness of the QMS by preparing for internal and external audits, updating processes, and maintaining compliance.

• Continuous Improvement:

• Lead initiatives to establish and implement quality improvement programs.
• Coordinate post-market data collection and analysis to support product safety and performance monitoring.

• Document Control:

• Oversee document management processes to ensure policies, procedures, and records are up-to-date and accessible.

• Risk Management:

• Contribute to maintaining risk management documentation, including risk analyses and FMEAs.

• Training & Awareness:

• Support company-wide training initiatives to promote adherence to quality and compliance best practices.