Pediatrics Physician

Doctor's Choice Placement Services, Inc.; Comunidad Valenciana; Presencial; EUR 30.000 - 60.000; Jornada completa

Descripción de la vacante

Una empresa innovadora en el sector de la salud busca un profesional en Gestión de Calidad para unirse a su equipo. En este papel, serás responsable de mantener y mejorar el Sistema de Gestión de Calidad, asegurando el cumplimiento con estándares internacionales. Trabajarás en un entorno dinámico y colaborativo, donde tendrás la oportunidad de contribuir a la mejora continua y al desarrollo de productos de vanguardia. Ofrecemos un ambiente de trabajo flexible y remoto, junto con oportunidades de crecimiento personal y profesional. Si estás listo para hacer una diferencia y unirte a un equipo ambicioso, esta es tu oportunidad.

Servicios

Entorno de trabajo remoto ilimitado

Oportunidades de aprendizaje y desarrollo

Presupuesto para formación

Acceso a Wellhub (Gympass)

23 días de vacaciones

Eventos regulares de equipo

Días libres en tu cumpleaños

Medias jornadas el 24 y 31 de diciembre

Formación

• 2+ años de experiencia en Gestión de Calidad en la industria regulada.
• Conocimiento sólido de normas y regulaciones de sistemas de calidad.

Responsabilidades

• Asistir en el mantenimiento del Sistema de Gestión de Calidad de Idoven.
• Gestionar evaluaciones de proveedores para asegurar el cumplimiento.

Conocimientos

Gestión de Calidad

Cumplimiento Normativo

Análisis de Datos

Comunicación

Colaboración Interfuncional

Educación

Licenciatura en Ciencias de la Salud o Ingeniería

Herramientas

ISO 13485

ISO 9001

EU MDR

FDA 21 CFR 820

Descripción del empleo

Crear una alerta de empleo para esta búsqueda

Cardiologist • Gijón

Descripción del trabajo

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 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

• 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.
• Support the processing of customer feedback and complaints, ensuring timely and compliant responses.
• Manage supplier evaluations and re-evaluations to ensure compliance with quality standards.
• Assist in ensuring the audit-readiness of the QMS by preparing for internal and external audits, updating processes, and maintaining compliance.
• Lead initiatives to establish and implement quality improvement programs.
• Coordinate post-market data collection and analysis to support product safety and performance monitoring.
• Oversee document management processes to ensure policies, procedures, and records are up-to-date and accessible.
• Contribute to maintaining risk management documentation, including risk analyses and FMEAs.
• Support company-wide training initiatives to promote adherence to quality and compliance best practices.

Requirements

• 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).
• 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.

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.

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!

At IDOVEN, we believe in hiring top talented people like you - ambitious, forward thinkers who want to make a difference in the world and have an impact.