Senior Quality Assurance Specialist

1 day ago


Kolkata, West Bengal, India beBeeMedicalDevice Full time ₹ 2,30,40,000 - ₹ 2,59,20,000
Job Overview

We are seeking a seasoned medical device expert to lead quality management initiatives.

About the Role
  • This is a senior-level position that requires approximately 10 years of professional experience in relevant fields of healthcare products or related activities.
  • The ideal candidate will possess comprehensive knowledge of ISO 13485, MDD 93/42/EEC, Indian Medical Device Regulations, and their application.
  • Experience with Risk Management EN ISO 14971 and solid understanding of non-active devices and sterilization processes are also essential.
Key Responsibilities
  • Collaborate with a team of assessors/auditors to drive quality improvement.
  • Develop and implement quality management systems to ensure regulatory compliance.
  • Conduct audits and assessments of medical devices to identify areas for improvement.
Requirements
  • Bachelor's degree in a relevant field such as engineering, science, or medicine.
  • Proven track record in quality management and regulatory affairs.
  • Demonstrated expertise in medical device regulations and standards.


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