Description

• Proactively identify Supplier quality issues, their causes and viable solutions.
• Effectively and collaboratively implement corrective actions to reduce and/or eliminate future occurrence.
• Interpret and implement ISO9000/13485 and FDA standards.
• Ensure corrective and preventive measures meet acceptable standards of robustness and effectiveness. Resolve components/material failures and focus actions on the root cause.
• Assure compliance to procedures and timely completion of SCAPAs and audit findings.
• Investigate and report corrective action effectiveness and timeliness.
• Support product continuation by assuring the quality of the components used in manufacturing and working supplier/component quality related issues to resolution.
• Manage supplier risks to prevent acceptance of sub-standard products.
• Implement supplier process controls and auditing strategies.
• Drafting documents for existing and new suppliers for the remediation procedure.
• Accessing SAP for pre-production sourcing data (purchase history).
• Working in parallel with suppliers and other cross functional team on any non- conformances that occur during production.
• Review and approve changes to purchased materials used in production.
• Ensure compliance of suppliers through leading and participating in supplier audits.
• Assure quality systems of OEMs, contract manufacturers and suppliers are maintained, and acceptance criteria are in alignment with component/product use and customer expectations. Develop and maintain Quality Agreements with suppliers.
• Develop qualification/validation plans and reports to assure components, materials and suppliers meet specified requirements and performance goals.
• Communicate and facilitate technical objectives between Customer and supplier.
• Develop and maintain inspection procedures for components and materials to support receiving inspection.
• Performing Capability Analysis (CpK, Normality, T-Test,) utilizing Minitab.
• Support and/or lead teams that develop new materials or implement significant supply chain changes.
• Participate in component and process Risk Assessments at suppliers.
• Promote continuous improvement using tools such as Lean, Six Sigma and Kaizen.
• Prepare and report supplier performance metrics (QMR, NCMR Reduction)

Degree requirement: Bachelor degree in Industrial Management or closely related field