Medical Device Quality Assurance Specialist

3 days ago


Mount Abu, Rajasthan, India beBeeQuality Full time ₹ 10,00,000 - ₹ 15,00,000

Job Overview

We're looking for a Quality Assurance Professional to help us ensure the quality, safety, and regulatory compliance of our products.

  • Main Responsibilities:
  • Implementing and maintaining a Quality Management System (QMS) in accordance with industry standards.
  • Identifying, interpreting, and ensuring adherence to relevant medical device regulations.
  • Creating, reviewing, and controlling technical files, regulatory submissions, and internal procedures.
  • Providing QA/RA input and support for design and development activities.
  • Participating in risk management activities throughout the product life cycle.
  • Monitoring device performance, investigating customer complaints, and managing vigilance reporting.
  • Supporting the management of supplier quality and compliance.
  • Conducting internal audits and leading initiatives to improve processes.

Required Skills and Qualifications:

  • Regulatory Expertise: Deep knowledge of global medical device regulations and standards.
  • Problem-Solving and Attention to Detail: Crucial for interpreting regulations, documenting processes, and resolving issues.
  • Effective Communication Skills: To coordinate with internal departments and external stakeholders.
  • Educational Background: Bachelor's degree in a relevant field such as engineering, life sciences, or a related technical discipline.
  • Previous Experience: Previous experience in QA/RA within the medical device industry is an advantage.

What We Offer:

  • A dynamic work environment that supports professional growth and development.
  • Competitive salary and benefits package.


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