Job description
...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.
Essential Duties and Responsibilities:
2. Day to day management and coordination of (any of these can apply to various Quality Specialist positions):
- Appropriate and effective corrective and preventive (CAPA) actions 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.
- Non-Conforming report activities including preparation, tracking, documentation, documentation review and approval.
- Document Control activities through the electronic documentation system, including training of associates to read, review, and approve documents; and maintaining a fully compliant system.
- Maintains Quality Management System records, including Device History Records, Device Master Records (DMR) and supporting documentation.
- Review of production batch records / finished goods batch records (DHR’s) for accuracy and completeness for product disposition.
- Initiate and author Deviations and Non-conformances, provide support to business owners when needed.
- Participate in Customer Complaint Investigations (when applicable).
- Support various Change Control activities within Product & Process Design Changes, Design Transfer, Document, and Supplier portions of the Quality Management System.
- Quality warehouse functions such as periodic review of activities, process monitoring, procedure review, assistance with process improvements.
4. Assists in the gathering, trending and reporting of metrics that effectively measure and communicate product and process performance.
5. Works cross functionally with Quality Assurance team members to understand, identify gaps and propose changes to processes that affect quality systems compliance.
6. 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.
7. Fosters an environment of continuous quality management improvement.
8. Displays a positive, can-do attitude and assists colleagues with quality system problem identification, management and correction/prevention.
9. Other duties as requested
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.
Qualifications:
- Bachelor’s degree or 5 years required experience in medical device industry Including experience in the Armed Forces.
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2-5 years total career experience.
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Knowledge of cGMP (FDA QSR) and ISO regulations
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English
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Microsoft Word, Outlook, Excel, PowerPoint, Access
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Strong communication and interpersonal skills.
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Ability to obtain cooperation, develop a consensus and lead or influence cross-functional teams.
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Positive “can do” attitude.
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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.
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