A medical device company is seeking a Sr. Sourcing Engineer to join their team!

The Supplier Engineer is a key member of Materials Sourcing team, leading/supporting key sourcing identification, quality, service level, change or improvement assessments, and cost on sourced components and supplier manufacturing processes. Is the liaison between suppliers and the company's production units to execute supplier or the company's initiated changes and resolve technical problems. 

ESSENTIAL DUTIES AND RESPONSIBILITIES 

• Perform risk analysis activities and develop risk-justified product testing or validation plans and protocols; reviews/approves supplier protocols for validation or performance testing; set up and run product testing and protocols in accordance with project plans.
• Supports DCO, CAF, NCR, SCR reviews/approvals/initiation.
• Assists in the evaluation of supplier’s technical competencies, capabilities, and capacity to provide input into sourcing reliable and cost-effective material supply decisions.
• Consults with R&D and Manufacturing Eng, assesses product requirements, and studies product characteristics to select validation objectives and standards. Seeks and provides supplier feedback on DFM. Serves as the point of contact with suppliers as it relates to specifications or engineering changes and assists in the company’s supplier/material onboarding.
• Assist the Supply Quality Engineer in new and existing supplier audits as required and ensure that they are completed as required.
• Works with suppliers to identify root cause of nonconformities of product or process standard and offers recommendations for resolving deviations.
• Supports Continuous Improvement of Quality & Quality Systems, Service Capability and Total Cost of Ownership throughout the Supply Chain.
• Partners with Supplier Quality Engineering to support investigation of Material Quality issues as they arise and ensures that adequate corrective actions are identified, implemented, and controlled by Suppliers driving supplier accountability.
• Proactively conducts risk assessment on sourced materials and builds installed capacity and capability at suppliers
• Manages supplier change request assessments to ensure impact of requested change is analysed and appropriate testing and/or validation is conducted to successfully accept and implement the requested change.
• Partners with Supplier Quality Engineering to establish and report metrics for Supplier Performance Monitoring to ensure adequate controls are in place to prevent supplier nonconformances.
• Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA and applicable regulatory regulations.
• Support the Quality System and Quality Policy. Be aware of Quality System procedures and requirements, including regulatory requirements and training requirements for position activities. Inform responsible personnel of concerns involving product quality.
• Assist Materials department in setting up Stocking Programs, Kan Ban’s, VMI & VIP.
• Other duties as assigned.

EDUCATION/EXPERIENCE:                                                                                                                                                                                                                                                                                                                                                                          

• Bachelor in Engineering or technical field.
• 5 Years relevant experience; knowledge of guide catheters, extrusion, injection molding, is a plus
• Experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, the MDD, GMP, GDP procedures and requirements.
• and knowledge of relevant standards.
• Knowledge of operations techniques including Just-In-Time (JIT) manufacturing, benchmarking, and other quality and continuous improvement tools (Lean)
• Demonstrates Technical skills in risk management and remediation
• Ability to detail project plans effectively.
• Familiar with Design Control procedures and requirements.
• Experience with test method validation, product/process changes/validation 
• Excellent communications skills (both written and verbal) required.
• Ability to work independently or in team setting required.
• Working knowledge or experience in the purchasing of components and subsystems within a manufacturing and/or NPD environment