Medical Devices Assessor

1 day ago

Aurangabad, Maharashtra, India beBeeDevice Full time ₹ 12,00,000 - ₹ 15,00,000
Job Summary

We are seeking an experienced Senior Device Engineer to assess and audit medical devices for compliance with industry standards.

  • A minimum of 10 years of experience in healthcare products or related activities, such as research and development, manufacturing, quality management, or regulatory affairs.

Key Responsibilities Include:

  • Quality Management: With a strong focus on compliance and risk management, the ideal candidate will have at least 5 years of experience in quality management.
  • Risk Assessment: A solid understanding of EN ISO 14971 is essential, along with the ability to apply this knowledge to ensure effective risk assessment and mitigation.
  • Device Knowledge: Good knowledge of non-active devices, sterilization processes, and relevant regulations, including ISO 13485, MDD 93/42/EEC, and Indian Medical Device Regulations, is required.

This role offers a challenging opportunity for a skilled device engineer to make a meaningful contribution to the company's success. As part of our team, you will work collaboratively with assessors/auditors to drive results and growth.

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