• To be a technical focal point to monitor and work supplier quality issues directly with the manufacturer and communicate status on non-conforming parts/suppliers across all programs. Evaluate supplier performance, determine appropriate Inspection processes and provides guidance to Receiving Inspection function at the site level.
Key Responsibilities and End Results: (Essential responsibilities include but are not limited to the following):
• Establish and successfully execute supplier management plans which will align to overall business objectives
• Improve material quality by ensuring proper inspection methods and drawing requirements are communicated, understood, and delivered with suppliers
• Perform supplier audits and assessments of their processes and Quality Management Systems
• Disposition and correction of non-conforming material requiring advanced process / technical knowledge
• Manage and implement supplier change notices (SCN)
• Demonstrate knowledge of domestic and international requirements and standards such as FDA QSR Part 820, ISO 14971, ISO 13485, ISO 9001. Support internal, corporate, notified body, FDA, and other audits
• Responsibilities may include the following and other duties may be assigned
• Ensures that suppliers deliver quality parts, materials, and services
• Qualifies suppliers according to company standards and Supplier Program in receiving inspection
• Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur
• Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met
• Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation
• Drive improvements in shop floor quality control processes and procedures
• Develop and improve the plant quality organization’s ability to perform complex problem solving to more effectively address customer complaints, service deviations and internal corrective actions
• Generate reports and data analysis as required
• Assist to develop and confirm methods for reprocessing of assigned devices
• Write verification and validation documentation and conduct required testing as needed
• Perform testing and inspection functions including forensics and root cause analysis
• Author, revise, train, and provide support for production work instructions
• Identify new processing needs and perform continuous improvement to support sustaining efforts
• Lead and facilitate process improvement activities
• Role may include project and team management responsibilities
• Committed to building a positive culture
• Other responsibilities may be assigned & not all responsibilities listed may be assigned
Job Specifications: The minimum education and experience required to perform this job competently.
• Bachelor's degree required in Mechanical Engineering, Industrial Engineering, or Manufacturing
Engineering or closely related equivalent
• Minimum of 2 years of experience as a process, manufacturing, industrial, operations or quality engineer in
a sophisticated manufacturing/operations environment.
• Medical device, pharmacy, bioengineering, food or other FDA regulated industry a plus.
• Certified Quality Auditor and or Certified Quality Engineer preferred
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