Senior Supplier Quality Engineer

2 days ago

Kozhikode, Kerala, India beBeeSupplierQuality Full time ₹ 10,00,000 - ₹ 15,00,000

Job Title: Senior Quality Assurance Specialist

Key Responsibilities:

  • Develop and implement supplier quality strategies, policies, and risk management processes to ensure compliance with regulatory standards.
  • Lead the qualification, selection, and approval of suppliers in accordance with FDA, EMA, ISO 13485, ICH Q10, and GMP guidelines.
  • Conduct thorough supplier audits, assessments, and performance reviews to guarantee adherence to quality and regulatory requirements.
  • Oversee supplier corrective and preventive actions (CAPA), root cause analysis, and continuous improvement initiatives.
  • Collaborate with cross-functional teams to resolve supplier-related issues and drive improvement initiatives.
  • Monitor supplier KPIs (on-time delivery, defect rates, deviations, complaints) and implement strategies to enhance performance.
  • Support new product development by ensuring supplier capability for components, raw materials, and services.
  • Manage supplier change control processes and assess their 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, and IATF 16949 (if applicable).
  • 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.

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