Quality Assurance Manager

7 days ago

Alleppey, Kerala, India beBeeSupplier Full time ₹ 15,00,000 - ₹ 25,00,000

We are seeking an accomplished Senior Supplier Quality Engineer to join our organization. This is a pivotal role that will drive supplier quality strategies, policies, and risk management processes forward.

As Senior Supplier Quality Engineer, you will be responsible for developing and implementing supplier qualification, selection, and approval procedures in alignment with regulatory standards. You will also conduct supplier audits, assessments, and performance reviews to ensure compliance with quality and regulatory requirements.

Your key responsibilities will include overseeing supplier corrective and preventive actions (CAPA), root cause analysis, and continuous improvement programs. Additionally, you will collaborate with cross-functional teams to resolve supplier-related issues and monitor supplier KPIs, driving improvement initiatives where necessary.

In this role, you will support new product development by ensuring supplier capability for components, raw materials, and services. You will manage supplier change control processes and evaluate the impact on product quality and regulatory compliance.

Core Competencies & Skills:
  • Strong expertise in supplier quality management, auditing, and regulatory compliance.
  • In-depth knowledge of GMP, GDP, ISO 9001, ISO 13485, IATF 16949.
  • Proficiency in risk management, root cause analysis, CAPA, Six Sigma, and Lean methodologies.
  • Excellent communication, negotiation, and stakeholder management skills.
  • Ability to lead supplier development programs and strategic quality initiatives.
  • Experience in global supplier management and multicultural environments.
Qualifications:
  • Bachelor's/Master's degree in Engineering, Life Sciences, or related field.
  • 10+ years of experience in supplier quality assurance, preferably in pharma/medical devices/regulated manufacturing industries.
  • Certified Lead Auditor (ISO 9001/13485, GMP, or equivalent) preferred.
  • Six Sigma Green/Black Belt certification is a plus.

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