
Senior Supplier Quality Assurance Manager
14 hours ago
We are seeking an experienced professional to manage supplier quality assurance, development, and compliance in regulated industries.
This role involves ensuring suppliers meet company, industry, and regulatory standards by leading audits, driving quality improvement initiatives, and building strong partnerships.
Key Responsibilities:- Develop and implement supplier quality strategies, policies, and risk management processes.
- Lead supplier qualification, selection, and approval in alignment with regulatory standards.
- 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, 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.
- 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.
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