Quality Assurance Professional

3 days ago

Ghaziabad, Uttar Pradesh, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 12,00,000

Job Overview:

Key Responsibilities
  • Maintain a Quality Management System to ensure compliance with industry standards.
  • Interpret and ensure adherence to relevant medical device regulations for market entry and ongoing compliance.
  • Develop, review, and control technical files, regulatory submissions, quality agreements, and internal procedures.
  • Provide QA/RA input and support for design and development activities to ensure compliance from the outset.
  • Participate in risk management activities throughout the product life cycle to identify and mitigate potential hazards.
  • Monitor device performance in the market, investigate customer complaints, and manage vigilance reporting.
  • Manage supplier quality and compliance.
  • Conduct internal audits and lead initiatives to improve processes and ensure adherence to QMS requirements.

Required Skills & Qualifications:

Key Expertise
  • Regulatory Compliance: Deep understanding of global medical device regulations and standards.
  • Problem-Solving & Attention to Detail: Essential for interpreting regulations, documenting processes, and resolving issues.
  • 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.
  • Professional Experience: Previous experience in QA/RA within the medical device industry is highly valued.

This role presents an opportunity to drive quality excellence and contribute to the success of our organization.

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