Specialist III, Change Control

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 Specialist III, Change Control. The Change Control Specialist III performs change management activities used to maintain quality processes required for Medical Device manufacturers and initial distributors including compliance with FDA, GMP, ISO, and applicable regulatory requirements. This position is responsible for overseeing day-to-day management of change control activities for processes and products within Sysmex's Quality Management System. Leads or supports cross-functional implementation of change projects at SAI and SRA to improve quality system process interactions with internal and external stakeholders.

Essential Duties and Responsibilities:

1. Manages the execution of product and process Change Control activities for applicable business activities at Sysmex America, Inc. and Sysmex Reagents America, Inc.
2. Drafts, evaluates, and approves Change Control assessments. Provides guidance on change documentation and ensures changes are appropriately risked, justified, and implemented.
3. Serves as the system administrator and subject matter expert (SME) for QMS Change Control and Document Control software modules.
4. Acts as the primary Change Control representative for the Quality System coordinating the intake, evaluation, and response(s) to internal and external stakeholders.
5. Provides support for the Document Control System, ensures accuracy and compliance of controlled documentation.
6. Ensures compliance with applicable regulations, internal policies, and global processes related to manufacturer change control, 3rd party vendor notifications, and associated document assessments.
7. Maintains and analyzes quality metrics for data trending and reporting to internal and external stakeholders.
8. Supports continuous improvement initiatives and CAPA activities within assigned areas. Identifies and leads process or product improvement efforts aimed at enhancing quality and efficiency.
9. Supports internal compliance audits and quality system oversight activities, including preparation for internal audits, external audits, and regulatory inspection.
10. Other duties as assigned.

Percentage of Travel: Up to 10%

Physical Risk: Regular exposures to risk that may require special training and precautions.

* Bachelor's degree required, and minimum 5 years required in Quality Assurance, Change Management experience a plus.

* 5-10 years total career experience.
* Knowledge of cGMP (FDA QSR) and ISO 13485 regulations is required.

* Strong oral and written communication and interpersonal skills.
* Ability to present training to diverse audiences.
* Ability to read, analyze and interpret technical and regulatory literature and journals, and governmental legislation and regulations.
* Ability to write reports, business correspondence, and policy and procedure manuals.
* An ability to effectively present information in written form, or for presentation to management, employees, customers, or regulatory agencies.
* Ability to define problems, collect data, establish facts, and draw valid conclusions using Quality System and Problem-Solving tools.
* Microsoft Word, Outlook, Excel, PowerPoint, Access, SAP, Veeva
* Effective teamwork and leadership skills.

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.