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As a Specialist, Quality Supplier at Baxter Healthcare Corporation, you will be at the forefront of ensuring outstanding supplier quality performance. This pivotal role involves collaborating with both internal teams and suppliers to improve the quality of Baxter products and services. You will play a crucial part in assuring that our products meet international ISO13485/ISO9001 standards and relevant regulatory requirements. Your expertise in manufacturing processes and applications will be essential in driving improvements and achieving flawless quality components.
Job Responsibility:
Manage audit failures and systemic issues (SCARs) with suppliers to improve processes and product quality
Review supplier-submitted change requests related to supplier moves and projects
Develop and oversee supplier audit programs, and act as the SQE representative for internal and external audits
Direct product and compliance-related supplier risk management approaches when necessary
Participate in developing partnerships with key suppliers
Assess and handle supplier scorecards along with corresponding activities
Perform part qualifications for PMI Engineering changes and provide quality input for supplier business reviews
Responsible for problem-solving based on rolling top 5 supplier issues
Input and participate in Supplier Quality Council (SQM) and conduct mandatory periodic supplier re-evaluations
Own, train, and ensure smooth implementation of process improvements (Process Excellence Engineering)
Develop risk reduction plans for provisional suppliers
Ensure quality terms and conditions with suppliers are adequate
Requirements:
Extensive knowledge of metals and practical experience in metrology, testing, inspection, and analysis techniques
Demonstrated strong analytical, problem-solving, teaming, and communication/interpersonal skills
Computer proficiency in Word, Excel, PowerPoint, and databases
Experience in the medical device or automotive industry, specifically in developing and deploying quality systems, process controls, and continuous improvement methods (QSRs, ISO9000/QS9000, ISO13485)
Primary/secondary party compliance auditing experience
Ability to work independently and methodically manage projects