This position is responsible for maintaining and improving supplier quality through supplier validation, technical troubleshooting, execution, training, and other supplier quality engineering activities. Essential Duties and Responsibilities Collaboration and coordination with the purchasing, production and engineering departments in relation to the quality of the suppliers. Management of SCNs/SCRs to avoid line-down situation and follow-up and closure of changes required by suppliers (SCRs). Perform process validation such as IQ, OQ & PQ. PPAP experience preferred. Act as an Technical SME for processes such as Injection Molding, Blow Molding, Compression/Transfer Molding, Extrusion. Maintenance of supplier records (ASL, SCAR). Maintenance and improvements to the supplier quality metrics process Qualification of raw materials through the Quality Assessment System (AQA)/PPAP Opening, monitoring, investigation, effectiveness review and closure of Corrective Actions required of suppliers (SCARs) Up to 25% travel needed. Know and apply the policies and procedures of the ISO 13485, 21 CFR part 820 Quality Systems and any other system that the company requires for its operation. Qualifications Degree completed in Industrial, Electrical, Mechanical Engineering, or equivalent. Five to ten years of professional experience as a preferred provider in the medical industry, or automotive, is required. ASQ CQE preferred Proficiency in English, written and conversational language for document generation and supplier management. Minimum 5 years of experience in supplier quality, process engineering, R&D roles. Experience in quality audits and supplier evaluation. Ability to analyze data, and trends for problem solving. Knowledge of reading blueprints, DIMENSIONS and geometric tolerances. General knowledge of the statistical control process, measurement and analysis systems. Knowledge of ISO 13485 System Quality Standard, FDA 21 CFR Part 820. Ability to plan and conduct effective meetings and group presentations. #J-18808-Ljbffr