Senior IVD Quality Assurance Specialist

1 day ago

Goa, India beBeeAssurance Full time ₹ 2,00,00,000 - ₹ 2,50,00,000

Quality Assurance Leader Position

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  • Job Description:

The Quality Assurance Leader is responsible for establishing, maintaining, and continually improving the Quality Management System (QMS) in compliance with international regulations across the full lifecycle of In-Vitro Diagnostics (IVD) products.

This role will provide QA oversight across manufacturing and post-market activities, ensure regulatory compliance, drive continuous improvement initiatives, and foster a strong quality culture. The incumbent will report to the Head of Quality Assurance and work closely with cross-functional teams.

Key Responsibilities:

  • Oversee document and record control, deviations, change control, incidents, Out-of-Specification (OOS), and quality risk management processes.
  • Manage Nonconformance and Corrective Action Preventative Action (CAPA) processes: lead root cause analysis, ensure implementation of effective corrective/preventive actions, and report CAPA trends to QA Head.
  • Plan, monitor, and support internal and external audits; confidently manage regulatory inspections.
  • Identify, design, and implement training programs for QA and cross-functional teams to promote a culture of quality and compliance.
  • Drive continuous improvement through proactive risk management and collaboration.

Requirements:

  • Strong understanding of IVD/Molecular Biology products.
  • In-depth knowledge of ISO 13485:2016 and ISO 14971 (Risk Management).
  • Proven ability to lead audits and regulatory inspections successfully.
  • Strong leadership, interpersonal, and team management skills.
  • Excellent collaboration and stakeholder management abilities.
  • Proactive and solution-oriented mindset, with a focus on quality culture.
  • High attention to detail and risk-based thinking.

Experience:

  • 12 to 15 years of experience in the IVD industry, with at least 3 to 5 years in a leadership/managerial role.

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