QA Compliance Expert

1 day ago

Shimoga, Karnataka, India beBeeQualityAssurance Full time ₹ 12,00,000 - ₹ 20,00,000
Quality Assurance Specialist Job Summary

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

Key Responsibilities:
  • Implement and maintain a Quality Management System (QMS) that ensures products meet quality, safety, and regulatory standards.
  • Identify, interpret, and ensure adherence to relevant medical device regulations for market entry and ongoing compliance.
  • 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 and Qualifications:
  • Deep knowledge of global medical device regulations and standards.
  • Excellent problem-solving and attention to detail skills.
  • Strong communication skills for coordinating 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.
About This Role:

This role requires a high level of expertise in quality assurance and regulatory compliance. The successful candidate will have a strong understanding of medical device regulations and standards, as well as excellent problem-solving and communication skills.

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