Quality Assurance Consultant (Software As Medical Devices) | 100% Remote Medical Devices · Port[...]

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!

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