Description

CSupplier Quality Engineer needed to perform the following Job duties :

• Demonstrate knowledge of domestic and international requirements and standards such as FDA QSR Part 820, ISO 14971, ISO 13485, ISO 9001
• Assess potential new suppliers for technical, quality and manufacturing capabilities.
• Provides technical support for the introduction of components from a new supplier
• Assure quality systems of OEMs, contract manufacturers and suppliers are maintained, and acceptance criteria are in alignment with component/ product use and customer expectations.
• Generate and maintain incoming inspection procedures.
• Assist in generating component specifications.
• Generate test protocols, monitor testing, issue qualification test reports and approve components for use in products.
• Participate in Component Qualification activities for New Product Implementation with existing and new suppliers.
• Analyze incoming material defects. Communicate Non- Conformance Issues with Suppliers.
• Develop qualification/ validation plans and reports of electronic components to assure components, materials and suppliers meet specified requirements and performance goals.
• Issue Supplier Corrective and Preventive actions as needed and review all investigative analysis from Supplier.
• Conduct root cause analysis activities in order to understand and resolve product and process issues.
• Investigate field failures related to supplier materials. Develop corrective action plan where necessary.
• Qualification of new suppliers and support of supplier/material changes
• Establish quality agreements with critical suppliers
• Manage the supplier change notification process, determine required actions for supplier changes, route to responsible subject matter experts, and assure change assessments are properly documented.
• Promote continuous improvement using tools such as Lean. Six Sigma and Kaizen.
• Support Material Review Board (MRB) evaluations of material deficiencies
• Manage the Supplier Corrective Action Request (SCAR) system
• Maintain the approved supplier list (ASL)
• Develop reports based on specifications using MATLAB.
• SAP ERP access to perform sourcing actions and purchase history for Supplier Segmentation Remediation.
• Maintain supplier documentation and files
• Provide quality systems input to suppliers such as, but not limited to: statistical process control, gage R&R studies, and capability studies
• Own supplier quality performance and measurement KPIs and participate in supplier performance reviews. Enable reporting of metrics for monthly reviews.
• Implement Production Part Approval Process (PAPP).
• Ensure regulatory compliance in area of responsibility to GMP of all medical device regulatory agencies.
• Review and audit the deliverables including: Control Plans, Capability Plans, Capability Studies, Part layouts, Gage design, Gage R&R, PFMEA, DFMEA.
• Demonstrate a fundamental base in statistics, SPC, and process control methodologies.

Bachelor’s Degree required in Mechanical Engineering or Industrial Engineering or Engineering Technology or Industrial Management.