Specialist II, Product Complaint

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 assessment of complaints for Medical Device Reporting (MDR). Create and submit MDR and Mandatory Problem Reports (MPR) to the FDA and Health Canada as required. Initiate contact with the complainant as necessary for completion of assessment for reporting. Document justification for non-reportable events. Establish and maintain consistent rationale tools for reporting to Regulatory Authorities.
4. Escalates systemic issues to the appropriate quality system function. Open, monitor, assist in investigation, root cause analysis, effectiveness and closure of complaint related Non-Conformance Reports (NCR), Corrective and Preventive actions (CAPA) and/or Supplier Corrective Action Report (SCAR).
5. Process pertinent data and/or suspect product return (in collaboration with Operations team) for further investigation to the legal manufacturer for root cause analysis and resolution.
6. Assists in new hire Product Complaint Specialist on the job training consistent with complaint handling procedures and work instructions. Acts as complaint handling liaison for QA department.
7. Performs ad-hoc queries of complaint data. Prepares raw complaint data for analysis of complaint trends and assists with statistical analysis reports. Analyze complaint data based on safety and risk, and perform Hazard / Risk Analysis as required.
8. Following Document Control and Good Documentation Practices, maintains complaint related work instruction documents. Writes investigation summaries and consistent closure statements for mass complaint closures.
9. Other duties and projects as assigned.

• Associates degree in Medical Science, Health Sciences or Health care related field required with 3-5 years required experience in Medical Technology, Nursing, or healthcare related field including experience in the Armed Forces; or 3 years of experience in the Medical Device Industry with at least 2 years in Quality & Regulatory. 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 hematology, urinalysis, and coagulation. Sysmex product experience is preferred.
• Quality Systems knowledge including 21 CFR parts 820, 803, and ISO 13485. Knowledge of ISO 14971 is preferred.
• Basic knowledge of statistical methods 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.
• Strong analytical skills and problem solving ability.
• Ability to obtain cooperation, develop a consensus and lead or influence cross-functional teams.
• Ability to train peers using multiple methods and media to engage others.

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 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.