Senior Quality Assurance Specialist
1 day ago
We are seeking a seasoned professional to spearhead supplier quality initiatives, ensuring seamless collaboration with cross-functional teams and suppliers.
Key Responsibilities:
- Develop and implement comprehensive supplier qualification processes in accordance with regulatory standards (FDA, EMA, ISO 13485).
- Conduct thorough supplier audits, assessments, and performance reviews to guarantee adherence to quality and regulatory benchmarks.
- Oversee corrective and preventive actions, root cause analysis, and continuous improvement programs to enhance supplier performance and reliability.
- Collaborate closely with procurement, R&D, and operations teams to resolve supplier-related issues and drive process improvements.
- Maintain accurate records of supplier KPIs (on-time delivery, defect rates, deviations, complaints) and drive strategic quality initiatives to optimize supplier partnerships.
- Support new product development by ensuring suppliers possess the necessary capabilities for components, raw materials, and services.
Required Skills & Qualifications:
- Demonstrated expertise in supplier quality management, auditing, and regulatory compliance.
- In-depth knowledge of GMP, GDP, ISO 9001, ISO 13485, and associated regulations.
- 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.
- Able to lead supplier development programs and strategic quality initiatives that align with business objectives.
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