Senior Quality Development Specialist

1 week ago

Rajkot, Gujarat, India beBeeSupplier Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

Quality Assurance Manager

We are seeking a highly skilled professional to oversee supplier quality assurance, development, and compliance in regulated industries.

Key Responsibilities:

  • Develop and manage supplier quality strategies, policies, and risk management processes.
  • Lead supplier qualification, selection, and approval in alignment with regulatory standards (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 to resolve supplier-related issues.
  • Monitor supplier KPIs and drive improvement initiatives.
  • Support new product development by ensuring supplier capability for components and services.
  • Manage supplier change control processes and evaluate the impact on product quality and regulatory compliance.
  • Train internal teams and suppliers on quality systems and compliance expectations.

Core Competencies & Skills

  • Strong expertise in supplier quality management, auditing, and regulatory compliance.
  • In-depth knowledge of GMP, ISO 9001, ISO 13485, and risk management methodologies.
  • Proficiency in 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.

A proven track record in managing global suppliers and delivering measurable quality improvements is required.

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