Quality Management Professional

4 days ago


Dombivli, Maharashtra, India beBeeQuality Full time ₹ 60,00,000 - ₹ 1,00,00,000
Job Overview

We are seeking a highly skilled Quality Assurance Specialist to join our team. In this role, you will be responsible for ensuring that products meet quality, safety, and regulatory standards.

  • Implement and maintain a Quality Management System (QMS) like ISO 13485 to ensure compliance with medical device regulations.
  • Create, 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 non-conformity, and manage vigilance reporting.
  • Support the management of supplier quality and compliance.
  • Conduct internal audits and lead initiatives to improve processes and ensure adherence to QMS requirements.

Required Skills & Qualifications

  • Regulatory Expertise: Deep knowledge of global medical device regulations and standards is essential.
  • Problem-Solving & Attention to Detail: Strong problem-solving skills and attention to detail are crucial for interpreting regulations and documenting processes.
  • Communication Skills: Effective communication skills are necessary for coordinating with internal departments and external stakeholders.
  • Bachelor's Degree: A degree in a relevant field such as engineering, life sciences, or a related technical discipline is required.
  • Experience: Previous experience in QA/RA within the medical device industry is an advantage.


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