Lead Quality Assurance Specialist

5 days ago

Panjim, Goa, India beBeeQuality Full time ₹ 1,80,00,000 - ₹ 2,50,00,000
Senior Quality Assurance Manager Role Overview

The Senior Quality Assurance Manager will play a pivotal role in establishing, maintaining, and continually improving the Quality Management System (QMS) across the full lifecycle of IVD products. This critical position ensures compliance with ISO 13485:2016, EU IVDR, MDSAP, and Indian Medical Device Rules 2017.

Key Responsibilities:
  • Oversee document and record control, deviations, change control, incidents, OOS, and quality risk management processes.
  • Manage Nonconformance and CAPA processes by leading root cause analysis, ensuring implementation of effective corrective/preventive actions, and reporting CAPA trends to the 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 cross-functional collaboration.
Required Skills and Qualifications:
  • 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 strong focus on quality culture.
  • High attention to detail and risk-based thinking.
Desirable Attributes:
  • Strong analytical and problem-solving abilities.
  • Customer-focused and committed to compliance excellence.
  • Demonstrates a continuous improvement mindset.
  • Highly adaptable to a dynamic regulatory environment.
Experience:

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

Skillful Communication:
  • Strong verbal and written communication skills.
  • Ability to simplify and effectively communicate complex regulatory/quality requirements to diverse stakeholders.

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