Medical Device Quality Assurance Specialist

6 hours ago


Kanpur, Uttar Pradesh, India beBeeQuality Full time ₹ 20,00,000 - ₹ 25,00,000
Job Title: Medical Device Quality Assurance Specialist

In this role, you will have the opportunity to establish and lead Design Quality Control, Assurance, and Regulatory Affairs teams within a regulated industry.

The ideal candidate will have experience in developing and implementing quality management systems for medical devices, ensuring regulatory compliance with relevant standards and regulations.

Key Responsibilities:
  • Develop and implement quality management systems for medical devices.
  • Ensure regulatory compliance with relevant standards and regulations (e.g. CDSCO, FDA, MDSAP).
  • Lead/contribute to Electrical & Electronics technical solutions and products.
  • Design, analyze, integrate and document products, systems or subsystems.
  • Provide technical guidance and oversight to include concept development and peer/design review participation.
Requirements:
  • Minimum of Bachelor's Degree in relevant field (Engineering, Physics, etc.).
  • Experience in understanding and interpretations of Risk Management, Design Controls, Standards & Regulations, CDSCO, FDA, MDSAP, etc for Class 2 and Class 3 devices.
  • Ability to effectively communicate technical information in English (both written and oral).


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