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QA Engineer

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QA Engineer

Senior Quality Management R&D Engineer Software Development

Ambu

Augsburg

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Role description

Senior Quality Management R&D Engineer
Software Development
Shape the Future of Medical Innovation
Are you passionate about quality and compliance in medical device development? Do you have extensive experience in Quality Management across the product lifecycle— especially in Software Development?

As Senior QM R&D Engineer – Software Development, you will play a key role in ensuring that software and AI-enabled medical device solutions are developed, maintained, and improved in compliance with global regulatory and quality requirements. You will act as the Quality partner for software development projects and help drive excellence across the full product life cycle - from concept and development to release, maintenance, and post-market activities.

If you're ready to lead global R&D initiatives and drive continuous improvement, your next career move could be with
Ambu
.

Why Join Ambu?
Ambu is a global leader in medical device innovation, dedicated to improving patient care. At Ambu, we are advancing our ambition to achieve global leadership in endoscopy. As part of our ZoomAhead strategy, EndoIntelligence is a central part as a unified platform that combines hardware, software, and AI to deliver integrated endoscopy solutions across the full procedure journey. Software is a core part, enabling intelligent, connected solutions that improve patient care and clinical outcomes. As a Senior QM R&D Engineer Software Development, you’ll be part of a collaborative, forward-thinking team that values integrity, innovation, and impact.

Join a Team That Thrives on Collaboration and Diversity
We offer a collaborative and supportive team environment where mutual trust and collaboration are at the heart of everything we do. Our team brings together talented professionals from across the globe, creating a truly international workplace that values different perspectives and fosters innovation. If you are looking for a role where teamwork, inclusivity, and shared success define the culture, this is the place for you.

You’ll join a growing team of more than 42 quality engineers based in Ballerup, Denmark, Augsburg, Germany and Penang, Malaysia, with this role

located in Augsburg, Germany
Key Responsibilities
As a Senior QM R&D Engineer, you’ll play a pivotal role in shaping Ambu’s quality processes and driving excellence across global sites. Your key responsibilities include:

  • Acting as the Quality Management partner for software development and AI-related R&D projects
  • Driving and supporting risk management activities for software-based and software-enabled medical devices
  • Ensuring compliance across the software life cycle, including development, verification, validation, release, maintenance, and change control
  • Supporting the integration of cybersecurity into product development and maintenance processes
  • Providing quality oversight for AI-enabled medical device software, including lifecycle controls, documentation, traceability, and change management
  • Supporting design control, life cycle management, design changes, and post-market surveillance activities

Suggested candidate profile
Skills
Skills and experiences can be earned in many ways, and we understand that the best fit for the role cannot be prescribed on paper. You are however likely to succeed in this position if you have a strong foundation in quality and a proactive mindset. Depending on your previous experience this role can also be a Senior position. Ideally, your profile includes:

  • A BSc or MSc in Software Engineering, Computer Science, Biomedical Engineering, Quality Engineering, or another relevant technical discipline
  • Relevant experience in Quality Engineering / Quality Management within the medical device, digital health, health software, or another highly regulated industry
  • Hands-on experience working with software development projects in regulated environments
  • Solid knowledge of Software as a Medical Device (SaMD) and/or software embedded in medical devices
  • Experience with AI-enabled products or a strong understanding of quality and regulatory expectations for AI/ML-based medical software
  • Strong understanding of risk management, including both safety risk and cybersecurity risk
  • Experience working with global cross-functional teams and translating quality requirements into business-relevant, actionable guidance
  • In-depth knowledge of standards such as IEC 62304, ISO 14971, IEC 81001-5-1, ISO 13485, EU MDR, MDSAP, UK MD, QMSR
  • Understanding of the EU AI Act implications for high-risk AI systems in health/medtech is a strong advantage.

We Offer

  • A great Team that thrives on collaboration and values different perspectives and fosters innovation
  • Opportunities for personal and professional development
  • A dynamic, diverse and international work environment
  • A wide range of employee benefits—professional, social, and financial

Ready to Apply?
As an equal opportunity employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin. If you are ready to apply for the position, please apply as soon as possible. We will invite candidates for interviews on a continuous basis. Interviews are conducted on a rolling basis, so don’t wait—
apply today
and help us shape the future of patient care.

This is a saved copy of a posting published elsewhere. Postings get taken down without notice — check the employer's site before applying. mentors.coach is not the hiring party.

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Role description

Descripción:

Apoyar al área de Procesos de Negocio en el análisis, diseño, documentación y mejora de procesos operativos, asegurando que las iniciativas del área se ejecuten de forma ordenada, clara y alineada a las necesidades del negocio.

El rol tiene un fuerte componente operativo, pero también requiere criterio para proponer mejoras, priorizar iniciativas y servir como punto de conexión entre negocio, operaciones y tecnología.

Responsabilidades principales:

1. Análisis y documentación de procesos

  • Levantar información con diferentes áreas internas (Operaciones, Tecnología, Cumplimiento, Legal, Comercial, Finanzas).
  • Documentar procesos actuales y futuros (As-Is / To-Be).
  • Elaborar diagramas, flujos y documentación de procesos y reglas de negocio.
  • Identificar cuellos de botella, riesgos operativos y oportunidades de mejora.

2. Diseño y creación de workflows

  • Diseñar y mantener workflows operativos para la gestión o automatización de procesos.
  • Crear y actualizar workflows en archivos JSON, incluyendo validaciones y reglas básicas.
  • Trabajar en conjunto con áreas técnicas para la implementación de estos flujos en sistemas internos.
  • Ejecutar pruebas funcionales y asegurar el correcto funcionamiento de los workflows.
  • Documentar la lógica y reglas de cada flujo.

3. Gestión y seguimiento de iniciativas

  • Dar seguimiento a planes de trabajo, tareas y pendientes del área.
  • Coordinar reuniones, preparar minutas y dar seguimiento a acuerdos.
  • Identificar dependencias con otras áreas y alertar riesgos o bloqueos.
  • Apoyar en la priorización de iniciativas de acuerdo con impacto y esfuerzo.

4. Gestión de procesos y mejora continua

  • Tratar los procesos y workflows como activos vivos del negocio, sujetos a mejora constante.
  • Proponer ajustes o mejoras con base en la operación diaria y necesidades del negocio.
  • Traducir requerimientos del negocio en definiciones claras para su implementación.
  • Dar seguimiento a cambios y asegurar que los procesos cumplan con el objetivo para el que fueron diseñados.

5. Análisis operativo y preparación de entregables

  • Analizar información relacionada con procesos, indicadores operativos y desempeño de flujos.
  • Preparar reportes, presentaciones y resúmenes ejecutivos para la gerencia.
  • Mantener control documental de las iniciativas del área.

6. Soporte operativo y colaboración transversal

  • Administrar repositorios, controles y documentación del área.
  • Colaborar con distintas áreas en temas relacionados con procesos y operación.
  • Asegurar alineación entre procesos, sistemas y requerimientos internos o regulatorios.

Competencias técnicas

  • Conocimientos en análisis y rediseño de procesos (BPM).
  • Experiencia en modelado de workflows y manejo de estructuras JSON.
  • Conocimientos básicos de automatización de procesos o flujos operativos.
  • Capacidad para entender requerimientos funcionales y llevarlos a procesos claros.
  • Manejo intermedio de Excel, PowerPoint, Word y herramientas de diagramación.
  • Deseable: nociones básicas de APIs, lógica condicional o integraciones.
  • Deseable: experiencia o familiaridad con la industria de pagos, fintech o servicios financieros.

Competencias personales

  • Pensamiento analítico y enfoque práctico.
  • Organización y buena administración del tiempo.
  • Comunicación clara, tanto escrita como verbal.
  • Proactividad y sentido de responsabilidad.
  • Atención al detalle.
  • Capacidad para trabajar con múltiples áreas y prioridades al mismo tiempo.

Nuestra oferta de valor:

  • Seguro de Gastos Médicos Mayores
  • Comedor
  • Fondo de Ahorro
  • Oportunidades de desarrollo

¡Aplica hoy mismo dando clic en el botón SOLICITAR!

This is a saved copy of a posting published elsewhere. Postings get taken down without notice — check the employer's site before applying. mentors.coach is not the hiring party.

That is every opening in this category and country

Senior Quality Management R&D Engineer Software DevelopmentAmbu

Apply on the employer's site