Lead Quality Assurance Specialist

2 days ago


Coimbatore, Tamil Nadu, India beBeeQuality Full time ₹ 21,45,000 - ₹ 25,18,000
Job Opportunity: Quality Assurance Leadership

The ideal candidate will possess expertise in managing supplier quality assurance, supplier development, and compliance in regulated industries.

  1. Developing and implementing effective supplier quality strategies, policies, and risk management processes.
  2. Leading supplier qualification, selection, and approval in alignment with regulatory standards.
  3. Conducting supplier audits, assessments, and performance reviews to ensure compliance with quality and regulatory requirements.
  4. Overseeing supplier corrective and preventive actions (CAPA), root cause analysis, and continuous improvement programs.
  5. Collaborating with cross-functional teams to resolve supplier-related issues.
  6. Monitoring supplier KPIs and driving improvement initiatives.
  7. Supporting new product development by ensuring supplier capability for components, raw materials, and services.
  8. Managing supplier change control processes and evaluating the impact on product quality and regulatory compliance.
  9. Training, mentoring, and guiding internal teams and suppliers on quality systems and compliance expectations.

The successful candidate will have:

  • 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 include:

  • 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.

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

Key Responsibilities:

Assure Supplier Compliance:

  • Ensure compliance with quality and regulatory standards through regular audits and assessments.
  • Identify and mitigate risks associated with supplier non-compliance.

Develop and Implement Quality Strategies:

  • Design and implement effective supplier quality strategies and risk management processes.
  • Collaborate with cross-functional teams to drive quality improvement initiatives.

Lead Supplier Development Programs:

  • Develop and implement supplier development programs to improve supplier capabilities.
  • Collaborate with suppliers to address quality and compliance concerns.


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