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Quality Systems Analyst
hace 2 semanas
**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.
**Requirements**:
**Must-Have**:
- Bachelor’s degree required; Master’s degree preferred.
- 2+ years of experience in Quality Assurance or Quality Systems Management within a regulated industry, ideally medical devices.
- Solid understanding of quality system standards and regulations, including ISO 13485, ISO 9001, EU MDR, and FDA 21 CFR 820.
- Hands-on experience managing Non-Conformance and CAPA processes.
- Strong ability to identify process gaps and implement improvements effectively.
- Analytical mindset with excellent organizational skills.
- Ability to collaborate cross-functionally with various teams.
- Fluency in English (Spanish is a plus).
**Desired**:
- Experience managing supplier quality processes.
- Familiarity with post-market surveillance and quality data analysis.
- Knowledge of risk management standards (e.g., ISO 14971).
- Experience with software as a medical device (SaMD) or AI-driven medical devices.
**Benefits**
Be part of one of the most disruptive startups in HealthTech and AI and make a difference
Personal and professional growth as part of a fast-growing, international team
No corners cut in having the best tech equipment to do your job
Unlimited remote working environment, where you can choose to work from home and attend our Madrid office whenever you want to
Learning and development opportunities and training budget
Flexible Remuneration
- ️ Health Insurance
Access to Wellhub (Gympass), empowering your physical and mental wellness
**23 holidays, your birthday off, and December 24th and 31st half days to celebrate
Regular team events and Thursday happy hours
And much more
