Overview

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.

Responsibilities

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 and manufacturing release activities.

Essential Duties and Responsibilities:

1. Support document control system, including document implementation, coordination of SOP reviews, and archival.2. Coordinate training and technologist competency assessments3. Maintain on-site employee files with periodic reviews and updates4. Assist with quality review of internal documentation, such as equipment records, and testing records5. Assist Quality Assurance and Laboratory Staff with internal audits and external audits6. Assist with quality systems improvement activities related to CLIA compliance, such as LIMS implementation7. Other duties as assigned to support Laboratory Operations and Regulatory compliance

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.

Travel Requirement: None

Qualifications

• Bachelor’s degree or 2-4 years required experience in scientific or regulatory field, which may include experience in the Armed Forces. .
• 1-2 years of experience in a regulated industry, preferably in the medical field
• Experience with Quality Management Systems under GCP, CLIA, FDA, etc
• Proficient in English.
• Microsoft Word, Outlook, Excel, PowerPoint, and Access skills.
• 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.

Sysmex’s COVID-19 vaccination policy, consistent with its status as a federal government contractor and commitment to its customers and to providing a safe workplace for its employees, requires that, to the extent permitted by applicable law, all Sysmex employees must be fully vaccinated against COVID-19 by the latter of your start date. To the extent permitted by applicable law, any offer of employment extended will be conditioned upon the individual’s ability to provide proof of current vaccination status. Sysmex makes reasonable accommodations when needed for medical or religious reasons. However, vaccine exemption and other accommodation requests cannot be granted unless the individual is able, with the accommodation, to perform the essential functions of the job.

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.