
Senior Director of Quality Assurance
4 days ago
Job Title: Senior Supplier Quality Engineer
- Lead audits and drive quality improvement initiatives to ensure suppliers meet company, industry, and regulatory standards.
- Develop supplier quality strategies, policies, and risk management processes.
- Conduct supplier assessments and performance reviews to ensure compliance with quality and regulatory requirements.
- Oversee corrective and preventive actions, root cause analysis, and continuous improvement programs.
Key Responsibilities:
- Collaborate with cross-functional teams to resolve supplier-related issues.
- Monitor supplier KPIs (on-time delivery, defect rates, deviations, complaints) and drive improvement initiatives.
- Support new product development 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.
Core Competencies & Skills:
- Expertise in supplier quality management, auditing, and regulatory compliance.
- 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.
Qualifications:
- Bachelor's/Master's degree in Engineering, Life Sciences, or related field.
- 10+ years of experience in supplier quality assurance, preferably in regulated manufacturing industries.
- Certified Lead Auditor (ISO 9001/13485, GMP, or equivalent) preferred.
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