Senior Quality Assurance Specialist

3 days ago

Varanasi, Uttar Pradesh, India beBeeQuality Full time ₹ 1,20,00,000 - ₹ 2,00,00,000
Job Description

Our organization is seeking a highly skilled Senior Supplier Quality Engineer to join our team. The ideal candidate will have extensive experience in managing supplier quality assurance, supplier development, and compliance in regulated industries.

The role involves ensuring suppliers meet company, industry, and regulatory standards by leading audits, driving quality improvement initiatives, and building strong supplier partnerships.

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  • Develop and manage supplier quality strategies, policies, and risk management processes to ensure global regulatory compliance.
  • Lead supplier qualification, selection, and approval in alignment with regulatory standards (FDA, EMA, ISO 13485, ICH Q10, GMP).
  • Conduct thorough supplier audits, assessments, and performance reviews to guarantee quality and regulatory requirements are met.
  • Collaborate with cross-functional teams to resolve supplier-related issues and drive supplier KPIs (on-time delivery, defect rates, deviations, complaints) towards improvement.
  • Support new product development by ensuring supplier capability for components, raw materials, and services while adhering to global regulatory requirements.

Required Skills and Qualifications

We are looking for a candidate with the following skills and qualifications:

  • Strong expertise in supplier quality management, auditing, and regulatory compliance.
  • In-depth knowledge of GMP, GDP, ISO 9001, ISO 13485, IATF 16949 (if automotive/industrial).
  • Proficiency in risk management, root cause analysis, CAPA, Six Sigma, and Lean methodologies.
  • Excellent communication, negotiation, and stakeholder management skills.
  • 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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