Verification and Validation Specialist

5 dagen geleden

Apeldoorn, Gelderland, Nederland NonStop Consulting Voltijd

Verification and Validation Specialist

We are seeking a skilled Verification and Validation Specialist to lead the development and optimization of neutron activation processes for holmium microspheres. In this role, you will be responsible for designing and executing verification and validation protocols, ensuring alignment with technical specifications and regulatory standards.

Key Responsibilities:

  • Design and optimize neutron activation processes for holmium microspheres.
  • Lead and execute verification and validation protocols, ensuring alignment with technical specifications and regulatory standards.
  • Ensure compliance with regulatory standards such as ISO 13485, ISO 14971, and FDA 21 CFR Part 820.
  • Conduct risk assessments and develop mitigation protocols for potential hazards.
  • Prepare and present comprehensive technical documentation, ensuring traceability and compliance with internal and regulatory requirements.
  • Identify opportunities to improve process efficiency and safety.

Requirements:

  • Bachelor's or Master's degree in Biomedical Engineering, Nuclear Engineering, Material Science, Medical Physics, or a related field.
  • 2-5 years of experience in medical device development, with a focus on verification and validation processes.
  • Experience with neutron activation or radioisotope production is a strong plus.
  • Proficiency in risk management processes and V&V tools.
  • Strong understanding of regulatory standards (ISO 13485, ISO 14971, FDA QSR).
  • Excellent communication, analytical, and problem-solving skills.
  • Familiarity with radiation safety protocols; Radiation Safety certification is a plus.

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