Senior Quality Assurance Manager

6 hours ago


Jaipur, Rajasthan, India beBeeQuality Full time ₹ 15,00,000 - ₹ 20,00,000
Medical Device Engineer Position Overview

We are seeking a highly experienced Medical Device Engineer to lead the development and implementation of quality management systems.

The ideal candidate will have a strong background in medical devices and quality assurance, with expertise in regulatory frameworks, risk management, and sterilization processes.

The successful candidate will work collaboratively with cross-functional teams to drive process improvements and ensure effective implementation of new technologies.

  • Minimum 10 years of professional experience in healthcare products or related activities.
  • At least 5 years of relevant professional experience in quality assurance.

Responsibilities:

  • Assess and audit medical devices to ensure compliance with regulatory requirements.
  • Develop and implement quality management systems to ensure the highest standards of quality.
  • Collaborate with cross-functional teams to drive process improvements and ensure effective implementation of new technologies.

Requirements:

  • Excellent knowledge of regulatory frameworks, including ISO 13485, MDD 93/42/EEC, Indian Medical Device Regulations, and MDR 2017/745.
  • Experience with risk management, non-active devices, and sterilization processes.
  • Strong communication and collaboration skills.


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