Product Quality Manager

1 day ago


Kozhikode, Kerala, India beBeeQuality Full time ₹ 80,00,000 - ₹ 1,20,00,000
Job Summary

We are seeking a highly skilled Quality Assurance Specialist to support the effective implementation of our Quality Management System (QMS).

Key Responsibilities:

  • Develop and maintain QMS processes to ensure products meet quality, safety, and regulatory standards.
  • Ensure compliance with relevant medical device regulations for market entry and ongoing adherence.
  • 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 guarantee compliance from inception.
  • 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 enhance processes and ensure adherence to QMS requirements.

Required Skills & Qualifications:

  • Extensive knowledge of global medical device regulations and standards.
  • Excellent analytical and attention to detail skills.
  • Strong 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 advantageous.

Benefits:

A dynamic work environment and opportunities for professional growth.



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