Supplier Quality Engineer
Qualification: Bachelor Degree
- 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