Quality Assurance Specialist

3 days ago

Hyderabad, Telangana, India beBeeQuality Full time ₹ 20,00,000 - ₹ 25,00,000

Job Overview:

We are seeking an experienced professional to fill the role of Quality Assurance Specialist. The ideal candidate will bring deep expertise in quality management systems, regulatory frameworks, and compliance practices.

Main Responsibilities:

  • Serve as the primary subject matter expert on quality management systems, including ISO 9001 and other relevant standards.
  • Develop, implement, and maintain quality management system policies, procedures, and documentation.
  • Lead internal & external audits; ensure audit readiness and drive corrective actions.
  • Collaborate with cross-functional teams to ensure compliance across departments.
  • Provide training & mentorship on quality management principles, tools, and best practices.
  • Analyze quality data & metrics to identify trends and areas for improvement.
  • Support risk management, CAPA processes, root cause analysis, and participate in management review meetings.
  • Stay updated on regulatory changes and update quality management system documentation

Required Expertise:

  • In-depth knowledge of ISO 9001, ISO 13485, HIPAA, GxP, FDA regulations.
  • Strong understanding of:
    • 21 CFR Part 11 & Part 21.
    • Good Manufacturing Practices (GMP).
    • CSV Regulations.
    • Software as a Medical Device (SaMD).
    • IEC 62304 & 82304 Regulations.
    • Verification Testing.
    • Penetration Testing

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