About Us: GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.
Role Summary: The Supplier Quality Engineer is responsible for driving exceptional product quality for the patient safety, customer value beyond expectations, regulatory assurance, and optimized Cost of Quality for GEHC. This is a key technical position, affecting part quality for both installed base and NPI parts.
Essential Responsibilities: 1. Improve supplier quality performance for assigned suppliers via Quality Plan implementation. 2. Approve supplier selection through robust qualification processes. 3. Assure supplier compliance to GEHC QMS and regulatory requirements through supplier monitoring process. 4. Develop positive relationships and work closely with Global Sourcing Leaders and Modality Sourcing Leaders to manage and implement supplier/engineering changes, New Product Introductions, and transfers. 5. Interface with Suppliers, Engineering, Service, Manufacturing and Sourcing to drive Quality improvements that minimize the Costs of Quality. 6. Assure Corrective and Preventive Action plans are developed and executed at assigned suppliers in compliance with the CAPA process. 7. Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy to ensure compliance. 8. Develop and execute on Supplier Audit Plan. 9. All other duties as assigned by manager.
Quality Specific Goals: 1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position. 2. Complete all planned Quality & Compliance training within the defined deadlines. 3. Identify and report any quality or compliance concerns and take immediate corrective action as required. 4. Knowledge and understanding of GEHC Purchasing Controls Procedure and associated Work Instructions and operates within them to ensure that all purchased product and services conform to specified requirements. 5. Ensure a compliant and qualified supply base by conducting supplier evaluations.
Qualifications/Requirements: 1. Degree in an engineering or technical discipline or equivalent non-technical degree with experience in manufacturing, engineering or quality assurance. 2. Experience in manufacturing, engineering, quality assurance and sterility assurance. 3. Trained Lead Quality Supplier Auditor. 4. Proficiency with Microsoft Excel spreadsheet development and analysis. 5. Effective problem solving, root-cause analytical skills to lead and influence others to drive change (cross-functionally and globally). 6. Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies and in-depth understanding of site level products and related processes. 7. Able to use English as working language.
Desired Characteristics: 1. Ability to effectively communicate within all levels of the organization. 2. Experience in Industrial Sterilization of devices/single-use/medical products. 3. Demonstrated collaboration, negotiation & conflict resolution skills. 4. Excellent oral communication & report, business correspondence & procedure-writing skills. 5. Supplier quality management experience.
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