Chief Quality Assurance Officer

2 weeks ago


Malappuram, Kerala, India beBeeRegulatory Full time ₹ 10,00,000 - ₹ 15,00,000
Quality Assurance Specialist Job Description

We are seeking a highly skilled Quality Assurance Specialist to join our team.

Job Responsibilities:
  • Implement and maintain a Quality Management System (QMS) to ensure compliance with regulatory requirements.
  • Ensure adherence to medical device regulations for market entry and ongoing compliance, including identifying and interpreting key regulations.
  • Manage documentation, including creating, reviewing, and controlling technical files, regulatory submissions, 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.
  • 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:
  • Deep knowledge of global medical device regulations and standards.
  • Strong problem-solving skills and attention to detail.
  • Effective 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.
  • Previous experience in QA/RA within the medical device industry is an advantage.


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