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This is the time to let your talent come to life. To maximize your knowledge and use it for the greater good. To work with the best professionals using state-of-the-art technology, and improve lives with your innovative ideas and ambitious dreams. Find a better way: the Sysmex Way.
...to improve the lives of others.
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.
...to build a promising future.
We currently have a great opportunity for a Quality Specialist II. The Quality Specialist, Level II is responsible for executing tasks in accordance GMP registered processes for Medical Device Manufacturing and Initial Distribution activities. This involves ensuring compliance with applicable FDA, Health Canada, and ISO regulatory requirements. The Quality Specialist, II is responsible for monitoring, inspecting, and proposing measures to correct or improve products and process, ensuring established quality standards are achieved.
Day to day activities can include: CAPA/NCRs, routine inspections of product and process, change control, risk management, administration of GMP enterprise software quality modules, and manufacturing release activities. The Quality Specialist II contributes to the development of materials, records, and documentation needed to ensure business processes remain in compliance with regulatory requirements.
Essential Duties and Responsibilities:
1. Supports the development and maintenance of key aspects within Sysmex’s quality systems, designed to meet the Quality Management System requirements and ensure compliance with Regulatory requirements.
2. Day to day management and coordination of (any of these can apply):
• Coordinate effective corrective and preventive (CAPA) actions with various business owners, including observations from the audit program, external regulatory agency inspections, manufacturing, post manufacturing, and other process/product non-conformances.
• Non-Conforming report activities including preparation, tracking, documentation, documentation review and approval.
• Administer Document Control activities through the content management system (CMS), includes assisting Sysmex associates in use of the system, as needed.
• Maintain Quality Management System records, including Device History Records, Device Master Records (DMR), and supporting product documentation.
• Review of production batch records / finished goods batch records (DHR’s) for accuracy and completeness for product disposition, including product release activities.
• Initiate and author Deviations and Non-conformances, provide support to business owners as needed.
• Participate in Customer Complaint Investigations.
• Support various Change Control activities: Product & Process Design Changes, Design Transfer, Document Change Control, Training Impact Assessment, Engineering Change Control, & Supplier Change Control, as needed.
• Collaborating with all levels of the organization in the development of documentation used within the Quality Training system, includes training impact assessments & curricula. Ensure business process documentation aligns with training requirements.
• Provide support for LMS, CMS, & QMS enterprise system releases, ensure they remain in a validated state.
• Support Credentialing activities of the Sysmex associates.
3. Perform and/or assists with internal audits, external audit, and supplier audits as required.
4. Assists in the gathering, trending, and reporting of Quality and Key Performance Indicator metrics that effectively monitor and measure product / process performance.
5. Works cross functionally with various business owners to understand, identify gaps, and propose changes to processes that impact Quality System compliance.
6. Fosters an environment of continuous quality management improvement.
7. Displays a positive, can-do attitude and assists colleagues with quality system problem identification, management, and correction/prevention.
8. Other duties as required.
Travel Percentage: 10%
Physical Risk: Regular exposures to risk that may require special training and precautions.
Physical Demands: Light physical effort. Routine handling of objects up to 20 pounds; prolonged (at least 50% of time) sitting, standing, keyboard or CRT work. May require periods of moderate discomfort due to noise, dust, lighting and/or other conditions.
Bachelor’s degree or 5 years required experience in medical device industry Including experience in the Armed Forces.
2-5 years total career experience.
Knowledge of cGMP (FDA QSR) and ISO regulations
English
Microsoft Word, Outlook, Excel, PowerPoint, Access
Sysmex is proud to be an EEO/Affirmative Action employer. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, age, sex, sexual orientation, gender identity or expression, color, religion, national origin, genetics, disability status, protected veteran status or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
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