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Headquartered in Kobe, Japan, Sysmex is located in Lincolnshire, Illinois. Renowned worldwide for the very finest in quality, innovative diagnostic equipment and information-management systems, we apply science to enhance the quality of life on a global scale. Our agile, resourceful team is committed to realizing critical breakthroughs in laboratory diagnostics, information technology, workflow analysis and life sciences for the clinical laboratory.
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We currently have a great opportunity available for a Quality Assurance Specialist II. The Sysmex Reagents America (SRA) Quality Specialist II performs activities used to maintain quality processes required for Medical Device manufacturers and initial distributors including compliance with ISO, FDA, GMP, OSHA and similar regulatory quality requirements. Activities include, evaluation of corrective and preventive actions, auditing of various company departments, and functions that impact the safety and effectiveness of our products. This position requires understanding of IVD reagent manufacturing, and support processes.
This position will be required to work a 7day/12hour shift schedule (work for 3 days/off for 4 during one week and then work for 4 days/off for 3 the following week). The weeks will alternate this way and the employee will also work alternating weekends. The hours will be 6:30am-6:30pm.
Essential Duties and Responsibilities:
- Performs day to day quality final product release function. Checks product quality; looks for defects, reviews and signs off on lot specific manufacturing documentation within Device History Record and SAP system software.
- Performs general quality system support for SRA reagent production activities, includes assisting production department in daily inspections and completing exception or non-conformance paperwork when product/process issues are identified.
- Day to day management and coordination of appropriate and effective Corrective and Preventive Actions (CAPA) throughout the SRA quality system in response to pertinent observations from the audit program, external regulatory agency inspections, and complaints.
- Develops and performs training programs at SRA related to Quality Systems and internal procedures as part of document control system requirements.
- Performs internal audits and supplier audits as required to support the SRA Quality System.
- Responsible for document and change control compliance. Processes new and revised documentation changes within Sysmex document control system, includes paper based documentation requirements at SRA.
- Participates in customer complaint investigations for SRA manufactured product.
- Assists in the tracking, gathering, and reporting of metrics that effectively measure and communicate SRA quality system performance.
- Completes special projects as assigned.
- Other duties as requested.