
Quality Assurance Specialist
4 days ago
We are seeking an experienced and skilled Supplier Quality Manager to lead our supplier quality assurance and development efforts.
">">Key Responsibilities:- ">
Develop and implement effective supplier quality strategies and policies to ensure compliance with regulatory standards.
Conduct supplier audits, assessments, and performance reviews to identify areas for improvement and drive quality enhancements.
Collaborate with cross-functional teams to resolve supplier-related issues and ensure alignment with global regulatory requirements.
Manage supplier corrective and preventive actions (CAPA), root cause analysis, and continuous improvement programs to optimize supplier performance.
Monitor supplier KPIs (on-time delivery, defect rates, deviations, complaints) and develop data-driven insights to inform supplier quality decisions.
Support new product development by ensuring supplier capability for components, raw materials, and services.
Train and mentor internal teams and suppliers on quality systems and compliance expectations to foster a culture of excellence.
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Strong expertise in supplier quality management, auditing, and regulatory compliance.
In-depth knowledge of GMP, GDP, ISO 9001, ISO 13485, and IATF 16949 standards.
Proficiency in risk management, root cause analysis, CAPA, Six Sigma, and Lean methodologies.
Excellent communication, negotiation, and stakeholder management skills to build strong relationships with suppliers and internal stakeholders.
Ability to lead strategic quality initiatives and drive business growth through improved supplier quality.
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Bachelor's or Master's degree in Engineering, Life Sciences, or related field.
10+ years of experience in supplier quality assurance, preferably in pharmaceutical, medical devices, or 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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