Senior Medical Device Engineering Expert

1 day ago


Bikaner, Rajasthan, India beBeeQuality Full time ₹ 18,00,000 - ₹ 25,00,000
Medical Device Audit Specialist

This role involves leading a team of assessors/auditors to evaluate medical devices against regulatory standards.

Key responsibilities include:

  • Leading a team of assessors/auditors to evaluate medical devices against ISO 13485, MDD 93/42/EEC, Indian Medical Device Regulations, and MDR 2017/745
  • Conducting risk management audits using EN ISO 14971 and identifying areas for improvement
  • Collaborating with cross-functional teams to develop and implement quality management systems

Requirements:

  • 10+ years of experience in medical devices or related fields, including research and development, manufacturing, and quality management
  • 5+ years of experience in quality management, preferably with knowledge of MDSAP and IMDR
  • Solid understanding of non-active devices, sterilization processes, and regulatory requirements

We are seeking experienced professionals looking to leverage their skills in medical device engineering and quality management.



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