Specialist I, Product Complaint

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 Product Complaint Specialist I. Product Complaint Specialist is responsible for independently accepting and processing complaints escalated from customer facing areas within Sysmex for products manufactured or distributed and serviced by Sysmex in accordance with medical device regulations and internal Sysmex procedures. The Specialist will ensure documentation of clear, complete and timely investigations that are supported by data, and can stand on their own.

Essential Duties and Responsibilities:

1. Follow departmental procedures for the evaluation of complaint information for acceptable content and supporting data. Process all complaints escalated from Sysmex functional areas with direct customer contact (Sales, Technical Assistance Center, Service, etc.) related to products manufactured and or distributed and serviced by Sysmex in a manner consistent with all laws and regulations for medical devices.
2. Interface with all investigators (original product manufacturers, and distributors) to ensure timely complaint investigation, escalation and closure. Perform complaint investigations for root cause as appropriate. Interpret investigative reports and data to provide investigation summaries, root cause and resolution as appropriate for complaint closure. Using Good Documentation Practices, write complaint information, investigations and closure statements in TrackWise.
3. Perform initial assessment of complaints for Medical Device Reporting; create and submit Medical Device Reports (MDR), and Mandatory Problem Reports (MPR) to the FDA and Health Canada respectively, as required. Initiate contact with the complainant as necessary for completion of assessment for reporting. Document justification for non-reportable events.
4. Escalates systemic issues to the appropriate quality system function. Monitor complaint related Non-Conformance Reports (NCR), Corrective and Preventive actions (CAPA) and/or Supplier Corrective Action Report (SCAR).
5. Provide input to the continual improvement of complaint handling processes.
6. Other duties and projects as assigned.

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.

• Associates degree and 3-5 years required experience in Medical Technology, nursing, or healthcare related field including experience in the Armed Forces required. Bachelor’s degree in Medical Technology or Nursing preferred.
• Certified Medical Laboratory Technologist / Technician or Registered Nurse with minimum of 3 years clinical experience preferred.
• Knowledge of basic hematology, urinalysis, coagulation.
• Quality Systems knowledge including 21 CFR parts 820 & 803 and ISO-9000, ISO 13485 is preferred.

• Excellent command of English both written and verbal; second language desirable (Spanish, French or Portuguese).

• Microsoft Office proficiency, including Microsoft Word, Outlook, Excel, PowerPoint. Experience with TrackWise is preferred.

• Strong communication and interpersonal skills.

• Ability to obtain cooperation to develop a consensus.

• Positive “can do” attitude. 

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.