Senior Medical Device Quality Assurance Specialist

24 hours ago

Rajkot, Gujarat, India beBeeQuality Full time ₹ 8,00,000 - ₹ 12,00,000

Job Title: Quality Assurance Specialist

Role Overview

This role involves overseeing the implementation and maintenance of a quality management system to ensure products meet regulatory standards.

Key Responsibilities
  • Implement and maintain a QMS in accordance with ISO 13485 and other relevant regulations, ensuring seamless product development.
  • Ensure adherence to medical device regulations for market entry and ongoing compliance, providing assurance that our products meet global requirements.
  • Develop, review, and control technical files, regulatory submissions, quality agreements, and internal procedures, maintaining accuracy and compliance throughout the process.
  • Collaborate with cross-functional teams to provide QA/RA input and support for design and development activities, ensuring alignment with business objectives.
  • Participate in risk management activities throughout the product life cycle, identifying potential risks and implementing mitigation strategies.
  • Monitor device performance in the market, investigate customer complaints, and manage vigilance reporting, ensuring timely resolution and continuous improvement.
Requirements
  • 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, with a strong understanding of global medical device regulations and standards.
  • Strong analytical and problem-solving skills, with the ability to identify and address complex issues.
  • Excellent communication and interpersonal skills, with the ability to coordinate with internal departments and external stakeholders effectively.

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