Highly Experienced Quality Assurance Specialist

2 days ago


Bareilly, Uttar Pradesh, India beBeeDevice Full time ₹ 25,00,000 - ₹ 30,00,000

Job Role:

Senior Device Engineer

We are seeking an experienced Senior Device Engineer to play a pivotal role in our Medical Devices-Assessor/Auditor team.

Main Responsibilities:

  • Evaluate and assess medical devices to ensure compliance with ISO 13485, MDD 93/42/EEC, Indian Medical Device Regulations, and MDR 2017/745.
  • Develop and implement risk management strategies using EN ISO 14971.
  • Collaborate with Assessors/Auditors to work on quality management projects.
  • Conduct thorough reviews of non-active devices and sterilization processes to ensure adherence to regulatory standards.

Requirements:

  • Minimum 10 years of professional experience in the medical devices industry or related activities.
  • 5+ years of relevant professional experience in quality management.
  • Solid knowledge of ISO 13485, MDD 93/42/EEC, Indian Medical Device Regulations, and MDR 2017/745.
  • Experience with Risk Management EN ISO 14971.
  • Solid knowledge of non-active devices and sterilization processes.


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