Quality Assurance Consultant (Software as Medical Devices) | 100% Remote from Portugal or Spain
We are looking for a "Quality Assurance Consultant (Software as Medical Devices)" to provide services to a multinational pharmaceutical company.
TASKS 🚀:
- Work closely with the software engineering team to establish a strong cross-functional relationship with the various teams involved.
- Manage digital project quality assurance across functions, ensuring timelines, project plans, and quality objectives are met, without managing the schedule handled by Project Managers.
- Promote organizational compliance with the quality system, QMS software, and SDLC framework.
- Provide CAPA support, address complaints, and assist with audits and QMS related to software development.
- Offer leadership and compliance support to ensure software quality assurance and implement and validate electronic systems following computer system validation requirements and procedures.
- Support the integration of ISO 14971 risk management, IEC 62366 usability engineering activities, and evaluate the value/feasibility of other regulatory guidelines to improve the platform.
- Provide quality oversight during risk assessments, Part 11, Annex 11, and regulatory evaluations.
SKILLS 🤹:
- Bachelor's or Engineering degree in Life Sciences, Software, Computer Science, Biomedical Engineering.
- Over 2 years of experience in software Quality Assurance within the digital health, medical device, or regulated industry, including a solid understanding of best practices in software quality engineering.
- Practical working knowledge of medical device regulations, including 21 CFR 820, 21 CFR Part 11, MDR, ISO 13485, ISO 27001, and ISO 14971, and familiarity with GCP/GVP practices.
- Excellent organizational, interpersonal, verbal, and written communication skills for dealing with multiple stakeholders and projects.
- Strong project management skills.
- Knowledge of agile methodologies (Agile, Kanban, or Scrum) and SAFE (Scaled Agile Framework).
- Fluent in English. Spanish is highly valued.
SCHEDULE 🕘:
- 08/09h-17/18h from Monday to Friday (flexible)
- Remote from Portugal or Spain.
Our goal is that you are well in every way!
- Categoría
- Medical Devices
- Ubicaciones
- Portugal (100% remote), Sant Cugat del Vallès
- Estado remoto
- Completamente remoto
Trabajamos con los mejores profesionales del sector y lo hacemos de forma:
Acerca de Ambit BST
¡Hola! Somos Ambit BST (Building Solutions Together), una empresa joven y dinámica con sede principal en Barcelona. Nuestra razón de ser consiste en generar un valor diferencial en la prestación de servicios y soluciones tecnológicas para las empresas, focalizándonos especialmente en el sector farmacéutico y de la Salud.
¿Qué nos hace especiales? Lo llevamos en el nombre: “construyendo soluciones juntos”. Nuestras herramientas para construir se basan en poner siempre a las personas en primer plano, ser adaptables y perseguir la mejora continua. En Ambit BST sabemos que tú eres la pieza clave para que podamos seguir construyendo juntos, así que ¡queremos encontrarte!”
Quality Assurance Consultant (Software as Medical Devices) | 100% Remote from Portugal or Spain
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