Medical Device Quality Assurance Specialist

hace 1 día

Zaragoza, Zaragoza, España Scarlet A tiempo completo
About this role:

We are seeking a highly skilled Medical Device Quality Engineer to join our team at Scarlet. As a key member of our Clinical Assessment team, you will play a critical role in ensuring the quality and safety of medical devices.

Key responsibilities:
  • Conduct audits and assessments of medical device quality management systems to ensure compliance with regulatory requirements.
  • Develop and implement assessment processes for AI management systems and relevant requirements.
  • Design and optimize efficient audit processes for customer data.
  • Collaborate with our team to develop and implement Scarlet's internal assessment tools.
  • Contribute to maintaining and expanding Scarlet's approvals in various jurisdictions and technologies.
Requirements:
  • Bachelor's degree in engineering, software engineering, computer science, physics, or equivalent.
  • Minimum of four years of professional experience in medical devices or related activities.
  • Minimum of two years of professional experience in quality management (e.g. ISO 13485, EU MDR, etc.).
  • Minimum of one year practical experience in software development, demonstrating knowledge of programming languages, software design, validation, testing, and debugging techniques.
  • Minimum of one year practical experience working with AI products.
Desirable skills:
  • Analytical reader with the ability to read and interpret normative texts.
  • Ferociously curious with a passion for understanding how things work.
  • Highly adaptable with experience working in different environments.
The Interview Process:

We have designed our interview process to ensure you get to fully understand the role and Scarlet's culture, and to ensure we get to know about your skills, expertise, and who you are.

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