Quality Management Professional

5 days ago


Bikaner, Rajasthan, India beBeeRegulatory Full time ₹ 60,00,000 - ₹ 1,20,00,000
Job Description

We are seeking a skilled Quality Assurance Specialist to join our team. As a key member of the organization, you will be responsible for implementing and maintaining a Quality Management System (QMS) that meets quality, safety, and regulatory standards.

This includes following guidelines such as ISO 13485 and identifying, interpreting, and ensuring adherence to relevant medical device regulations for market entry and ongoing compliance.

You will manage regulatory submissions, quality agreements, and internal procedures accurately, while providing QA/RA input and ensuring compliance from the outset.

Additionally, you will participate in risk management activities throughout the product life cycle to identify and mitigate potential hazards, and maintain vigilance reporting and monitoring device performance in the market.

Furthermore, you will support supplier quality and compliance through effective management and ensure adherence to QMS requirements by conducting internal audits and process improvement initiatives.

Required Skills and Qualifications

To be successful in this role, you will need:

  • Deep knowledge of global medical device regulations and standards.
  • Strong problem-solving skills for interpreting regulations, documenting processes, and resolving issues.
  • Bachelor's Degree in a relevant field such as engineering, life sciences, or a related technical discipline.
  • Previous experience in QA/RA within the medical device industry is an advantage.


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