Job Information
Minnesota State Job Bank Senior Supplier Quality Engineer in Plymouth, Minnesota
SENIOR SUPPLIER QUALITY ENGINEER St. Jude Medical / Plymouth, MN Assess potential new suppliers for technical, quality and manufacturing capabilities by using quality assessment tools and measurements . Provide technical support for the introduction of components from a new supplier. Generate and maintain incoming inspection procedures and train inspectors under these procedures. Develop and/or source inspection tools and equipment. Assist in generating component specifications, generating test protocols, monitoring testing, issuing qualification test reports and approving components for use in products. Write and execute validation and revalidation protocols/reports, and process validation procedures (Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)) , for the validation of new and existing processes, equipment and process changes. Provide input to design engineering on new component technology and assist in component selection with quality and reliability analysis. Analyze incoming material defects, dispositions and drive corrective action as necessary. Responsible for complying with appropriate policies, Good Manufacturing Practices (GMPs) and ISO requirements by preparing quality system reports . Communicate issues to suppliers, investigate field failures related to supplier materials and develop corrective action plans where necessary. Review new design specifications and provide input from component quality and manufacturability perspective. Manage cross functional team to assess, qualify and approve Supplier Change Notifications, including managing detailed timelines, testing, and budgets with the supplier, and internal Microbiology, Biocompatibility, engineering, Regulatory, Manufacturing, and Supply Chain teams. Resolve inspection methods and drawing requirements leading to product design changes/ process changes by utilizing statistical analysis of verification and validation test requirements and results with Minitab or related. Bachelor s degree or foreign academic equivalent in Engineering, Industrial Management, or a closely related field of study with at least 6 years of related professional engineering experience. In the alternative, will accept a Master s degree or foreign academic equivalent in Engineering, Industrial Management, or a closely related field of study with at least 4 years of related professional engineering experience. Each alternative requirement must possess experience in: (i) using quality assessment tools and measurements; (ii) writing and executing validation and revalidation protocols/reports, and process validation procedures (Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)); (iii) complying with Good Manufacturing Practices (GMPs) and ISO requirements by preparing quality system reports; and (iv) resolving inspection methods and drawing requirements leading to product design changes/process changes by utilizing statistical analysis of verification and validation test requirements and results with Minitab or related. Employer will accept any suitable combination of education, training, or experience. An EOE. 40 hrs/wk. $121,347 - $150,700/year. Send Resumes to: Abbott Laboratories, Elvia Salazar, Willis Tower, 233 S. Wacker Drive, Floor 25, Dept. 32, Chicago, IL 60606. Refer to ad code: SJM-0041-ES.