Quality Assurance Specialist

1 day ago


Thiruvananthapuram, Kerala, India beBeeSupplier Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

Job Title: Quality Assurance Specialist

Location: Bengaluru, Karnataka, India

Employment type: Part-time

Job Summary:

We seek an experienced supplier quality professional with 10+ years of expertise in managing supplier quality assurance, supplier development, and compliance in regulated industries (pharma/medical devices/regulated manufacturing industries). The role involves ensuring suppliers meet company, industry, and regulatory standards by leading audits, driving quality improvement initiatives, and building strong supplier partnerships.

Key Responsibilities:

  • Develop and manage supplier quality strategies, policies, and risk management processes.
  • Lead supplier qualification, selection, and approval in alignment with regulatory standards (FDA, EMA, ISO 13485, ICH Q10, GMP).
  • Conduct supplier audits, assessments, and performance reviews to ensure compliance with quality and regulatory requirements.
  • Oversee supplier corrective and preventive actions (CAPA), root cause analysis, and continuous improvement programs.
  • Collaborate with cross-functional teams (procurement, R&D, operations, quality) to resolve supplier-related issues.
  • Monitor supplier KPIs (on-time delivery, defect rates, deviations, complaints) and drive improvement initiatives.
  • Support new product development (NPD) by ensuring supplier capability for components, raw materials, and services.
  • Manage supplier change control processes and evaluate the impact on product quality and regulatory compliance.
  • Train, mentor, and guide internal teams and suppliers on quality systems and compliance expectations.

Requirements:

  • 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.
  • 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.

Preferred qualifications include certifications like Certified Quality Engineer (CQE), American Society for Quality (ASQ) certifications, and other relevant credentials.



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