Medical Device Quality Assurance Specialist

20 hours ago


Mumbai, Maharashtra, India beBeeDevice Full time ₹ 15,00,000 - ₹ 25,00,000

The Medical Device Quality Assurance Specialist role involves assessing and auditing medical devices to ensure they meet industry standards. With a strong background in healthcare products or related activities, the ideal candidate will have at least 10 years of professional experience in quality management.

Key Responsibilities:

  • Apply knowledge of ISO 13485, MDD 93/42/EEC, and Indian Medical Device Regulations to assess and audit medical devices.
  • Experience with Risk Management EN ISO 14971 is essential.
  • Work actively with a team of assessors/auditors to evaluate non-active devices and sterilization processes.

Requirements:

  • Minimum 5 years of relevant professional experience in quality management.
  • Solid knowledge of sterilization processes and non-active devices.
  • Strong understanding of industry regulations and standards.

Benefits:

The right candidate will be able to effectively manage and mitigate risks associated with medical device development, ensuring compliance with regulatory requirements. In return, we offer a dynamic work environment, opportunities for growth and development, and competitive compensation.

What We Offer:

  • A challenging and rewarding career opportunity in quality assurance.
  • Professional development and training opportunities.
  • A collaborative and supportive work environment.


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