Principal Quality Assurance Specialist

3 days ago

Panjim, Goa, India beBeeQuality Full time ₹ 9,00,000 - ₹ 12,00,000
Job Title

"Assistant Manager"

Job Description

The Assistant Manager / Manager - Quality Assurance plays a pivotal role in ensuring the Quality Management System (QMS) is established, maintained, and continually improved to meet international standards. Reporting to the Head of QA, this individual will oversee Quality Assurance operations across the lifecycle of In-Vitro Diagnostic (IVD) products.

This critical position provides QA oversight for manufacturing and post-market activities, ensures regulatory compliance, drives continuous improvement initiatives, and fosters a strong quality culture within the organization.

Key Responsibilities
  • Oversee document and record control processes, including deviations, change control, incidents, Out-of-Specification (OOS), and quality risk management.
  • Manage Nonconformance and Corrective Action Preventive Action (CAPA) processes: lead root cause analysis, ensure 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 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.
Benefits

A career as an Assistant Manager in Quality Assurance offers numerous benefits, including:

  • Opportunities for professional growth and development in a dynamic industry.
  • A chance to work with a talented team dedicated to excellence in quality assurance.
  • A competitive salary and benefits package.
Adaptability

Ability to adapt to a dynamic regulatory environment is essential for success in this role.

Skills & Attributes
  • High integrity and professionalism.
  • Strong analytical and problem-solving abilities.
  • Customer-focused and committed to compliance excellence.
  • Demonstrates a continuous improvement mindset.

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