
Senior Supplier Quality Assurance Manager
4 days ago
The ideal candidate will lead audits, drive quality improvement initiatives and build strong supplier partnerships to ensure suppliers meet industry standards.
A strong understanding of regulatory compliance is essential for success in this role. Key skills include:
- Supplier Qualification: Lead supplier qualification, selection and approval in alignment with regulatory standards.
- Audit and Compliance: Conduct supplier audits, assessments and performance reviews to ensure compliance with quality and regulatory requirements.
- CAPA and Continuous Improvement: Oversee supplier corrective and preventive actions (CAPA), root cause analysis and continuous improvement programs.
Experience working in regulated industries such as pharma/medical devices is highly desirable. The successful candidate should have a Bachelor's/Master's degree in Engineering, Life Sciences or related field, and a certified Lead Auditor (ISO 9001/13485, GMP or equivalent) certification.
Responsibilities and RequirementsKey Responsibilities:
- Develop and manage supplier quality strategies, policies and risk management processes.
- Conduct regular audits and assessments of suppliers to ensure compliance with quality and regulatory requirements.
- Drive quality improvement initiatives through the use of Six Sigma methodologies and Lean principles.
Requirements:
- 10+ years of experience in supplier quality assurance, preferably in pharma/medical devices or regulated manufacturing industries.
- Bachelor's/Master's degree in Engineering, Life Sciences or related field.
- Certified Lead Auditor (ISO 9001/13485, GMP or equivalent).
Preferred Skills:
- Six Sigma Green/Black Belt certification.
- Experience working in cross-functional teams including procurement, R&D, operations and quality.
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