Supplier Quality Specialist
hace 3 semanas
**Establish Quality Excellence with Abbott**
As a Supplier Quality Specialist at Abbott Laboratories, you will lead the establishment and maintenance of supplier quality engineering methodologies, systems, and practices that meet company and regulatory requirements. Your expertise will be crucial in providing engineering support for activities related to supplier selection and evaluation, material qualification, supplier performance, and receiving inspection.
**Key Responsibilities:**
• Develop and maintain supplier quality program policies, procedures, and forms to ensure compliance with company and regulatory standards.
• Supervise and mentor Supplier Quality Technicians and receiving inspection personnel to ensure quality excellence.
• Review and approve supplied product drawings and component quality plans to ensure adherence to quality standards.
• Manage the development of supplied product inspection procedures and first article requirements to ensure effective quality control.
• Provide engineering guidance to Receiving Inspection, including statistical analysis, measurement techniques, gage R&R studies, and inspection procedures.
• Assess supplier capabilities through direct visits, technical discussions, directed testing, and quality system audits to identify areas for improvement.
• Proactively communicate quality issues to suppliers through supplier quality system audits, supplier corrective action requests, and technical discussions.
• Participate in and provide engineering ownership for all supplied product Non-Conforming Material Reviews to ensure quality excellence.
• Contribute to and participate in supplier performance reviews to identify areas for improvement.
• Evaluate and develop Supplied Data Agreement partnerships with suppliers to ensure quality excellence.
• Apply sound engineering analysis and judgment to reduce the need for inspection in accordance with program policies.
• Collaborate with Manufacturing engineering to assess and address purchased product issues to ensure quality excellence.
• Support Supplier Assurance program requirements, including representing the Supplier Assurance function as a Core Team Member.
**Requirements:**
• Bachelor's degree or Technical Field (STEM careers).
• 6 months of Quality Inspection experience or equivalent internship in Receiving Inspection or Supplier Quality area.
• Knowledge of Quality tools/methodologies, including Root Cause Analysis, Fishbone, Is/Is Not, and Six Sigma or Process Control & Monitoring (SPC).
• Knowledge of FDA, GMP, and ISO 13485 standards.
• Technical writing skills.
• Ability to travel approximately 10-40%, including internationally.
• Advanced command of English.
• Prior medical device experience preferred.
• ASQ CQE, CQA, or CSQP certification.
• Experience with SAP supply chain modules or similar ERP system.
• Basic statistics knowledge.
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