Lead Auditor Specialist for In-Vitro Diagnostic Medical Devices

1 dia atrás


Lisboa, Lisboa, Portugal Sgs Tempo inteiro
About SGS

We are a leading testing, inspection, and certification company with a global presence.

Job Summary

We seek an experienced lead auditor to join our team in the field of in-vitro diagnostic medical devices. The successful candidate will be responsible for conducting audits, mentoring junior colleagues, and contributing to the development of our IVDR certification service.

Key Responsibilities:
  • Support the qualification of new auditors by witnessing their qualification audits and providing feedback.
  • Mentor junior colleagues and help coordinate the expansion of our IVDR auditor network.
  • Contribute to the continuous improvement of our processes and tools used in conducting IVDR conformity assessments.
  • Conduct on-site and remote audits, maintaining high standards of service delivery and ensuring compliance with regulatory requirements.
Requirements:

To be successful in this role, you will need:

  • A minimum of 4 years' experience in designing, manufacturing, or testing IVDs.
  • At least 2 years of quality assurance/quality management experience under a structured quality management system.
  • A university degree in a relevant science or engineering field.
  • Knowledge of EU IVDR 2017/746 and other relevant regulations.
  • Strong English written and verbal skills.
Benefits:

We offer a competitive salary range of $80,000 - $120,000 per year, depending on experience. Other benefits include opportunities for professional growth and development, a dynamic work environment, and a comprehensive compensation package.



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