Quality Technician
Vapotherm - cincinnati, OH
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SUMMARYThis position is responsible for complaint and regulatory reporting system activities including logging, investigation and closure of complaints. Additional responsibilities including assisting with responding to regulatory inquiries on complaints.PRIMARY RESPONSIBILITIES Manage complaint files, including opening files, evaluating complaints for complaint reportability in the US and worldwide, and preparing files for closure.Perform device failure investigations independently and as part of a team. Perform root cause analysis and identify improvement opportunities.Report weekly and monthly on complaint summaries and metrics.Follow up with in-house personnel regarding complaint investigation outcomes.Assist with responses to regulatory inquiries.ADDITIONAL RESPONSIBILITIESProvide support for internal, FDA, Notified Body and other municate with internal personnel regarding product issues.Perform other tasks related to the company's Quality Management System.KNOWLEDGE, YEARS OF EXPERIENCE AND EDUCATION3-5 years in the medical device industrySome experience handling and investigating complaints preferredProficient in MS Office toolsStrong critical thinking skills to evaluate and investigate customer complaintsEffective verbal and written communication skillsAssociates Degree or higher in Science or related field preferedMaintain strong attention to detail, especially during times of increased workloadWorking knowledge of ISO 13485: 2003, 21 CFR 820
Created: 2024-09-13