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. The Product Complaint Specialist I 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 Product Complaint Specialist I will ensure documentation of clear, complete and timely investigations that are supported by data, and can stand on their own. Opens, documents and actively monitors Corrective/Preventive actions for product complaints. Assists with statistical analysis and charting of complaint information, and prepares summary reports.
Essential Duties and Responsibilities:
1. Receive and 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. Apply departmental procedures to the evaluation of complaint information for acceptable content and supporting data. Independently evaluate information, reports and data and provide recommendations for performance of investigations.
3. Document complaints using SAP, and/or TrackWise, and distribute them for investigation using various means (SAP, Internet, Intranet, e-mail etc.). Receive, review and interpret investigative reports for complaint closure.
4. Perform initial assessment of complaints for Medical Device Reporting; create and submit Medical Device Reports (MDR), and Mandatory Reports to the FDA and Health Canada respectively, as required. Initiate contact with the complainant as necessary for completion of assessment for reporting.
5. Interface with all investigators (SAI, SRA, SCJ, original equipment manufacturers, and distributors) to ensure timely complaint investigation, escalation and closure. Perform complaint investigations for root cause as appropriate. Forward pertinent data for further investigation to the manufacturer for root cause analysis.
6. Prepare complaint data summaries and trend reports regarding complaints and complaint process key performance indicators. Prepare complaint related data for Management Review.
7. Provide input to the continual improvement of complaint handling processes.
8. Other duties and projects as may be 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.
Bachelor's Degree Required
Degree in in Medical Technology Preferred
3-5 Years Experience
Knowledge of basic hematology, urinalysis, coagulation. Knowledge of 21CFR Part 820 regulations, ISO-9000, ISO 13485 is preferred.
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
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 sex, sexual orientation, gender identity, color, religion, national origin, disability, protected Veteran status or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing.