Quality Management Professional

12 hours ago


Alleppey, Kerala, India beBeeQuality Assurance Full time ₹ 9,00,000 - ₹ 12,00,000

Role Summary

Job Responsibilities:

  • Implementing and maintaining a quality management system (QMS) to ensure products meet quality, safety, and regulatory standards.
  • Ensuring adherence to relevant medical device regulations for market entry and ongoing compliance.
  • Creating, reviewing, and controlling technical files, regulatory submissions, quality agreements, and internal procedures.
  • Providing QA/RA input and support for design and development activities to ensure compliance from the outset.
  • Participating in risk management activities throughout the product life cycle to identify and mitigate potential hazards.
  • Monitoring device performance in the market, investigating customer complaints and non-conformity, and managing vigilance reporting.
  • Supporting the management of supplier quality and compliance.
  • Conducting internal audits and leading initiatives to improve processes and ensure adherence to QMS requirements.

Requirements:

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

Key Performance Indicators:

  • Successful implementation and maintenance of QMS.
  • Adherence to regulatory requirements and standards.
  • Improved process efficiency and effectiveness.
  • Enhanced quality and safety of products.
  • Effective communication and collaboration with stakeholders.


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