Find a Better Way...
...to use your skills and experience.
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 available for a Quality Systems Specialist. The Quality Systems Specialist performs activities used to maintain quality processes required for Medical Device manufacturers and initial distributors including compliance with FDA, GMP, ISO, OSHA and similar regulatory quality requirements. Activities can include: evaluation of corrective and preventive actions, internal auditing of internal departments and functions that impact the safety and effectiveness of our products and customer satisfaction, document control activities, training compliance activities and manufacturing release.
Essential Duties and Responsibilities:
1. Supports the development and maintenance of key aspects in SAI Quality Systems, designed to meet the minimum regulatory and Quality requirements to assure compliance with FDA Quality Systems Regulations and ISO requirements.
2. Day to day management and coordination of (any of these can apply to various Quality Systems Specialist positions):
- Appropriate and effective corrective and preventive actions (CAPA) and CAPA coordination throughout the company's quality system in response to pertinent observations from the audit program, external regulatory agency inspections, complaints and other procedural/product non-conformances.
- Document Control activities through the electronic documentation system including training of associates to read, review and approve documents; and maintaining a fully compliant system.
- Detailed document review to perform product release activities.
3. Performs internal audits and supplier audits as required to support the SAI Quality System.
4. Assists in the gathering, trending and reporting of metrics that effectively measure and communicate quality performance.
5. Works closely with on site Quality Assurance team and cross-functionally in understanding, identifying gaps and proposing changes to processes that affect quality systems compliance.
6. Completes special projects as assigned.
7. Assist in Supplier Quality activities, including supplier evaluation, information gathering, risk assessment, etc.
8. Supports the company's deployment of Quality System processes and procedures and promotes ongoing education of the company's knowledge of the Quality System and regulatory requirements.
9. Other duties as requested.
- English fluency.
- Microsoft Word, Outlook, Excel, PowerPoint, Access.
- Strong communication and interpersonal skills.
- Ability to obtain cooperation, develop a consensus and lead or influence cross-functional teams.
- Positive “can do” attitude.
- Strong analytical skills and problem solving ability.
- Ability to travel up to 20%.
- Associate's degree required and 5 years experience relevant experience preferred in a diagnostics or medical device Quality Assurance environment. Bachelor's degree with a specialization in a science or health services field preferred.
- 5-7 years total career experience required.
- Knowledge of cGMP (FDA QSR) and ISO regulations.
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 disability, race, sex, color, religion, nationality or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing.