Medtronic
Sr Consumer Affairs Specialist (Finance)
Coordinate, review, evaluate and classify customer complaints to determine if they meet the regulatory criteria for reporting to the government agency, then generate and submit required reports within mandated timelines. Support post-market surveillance by gathering and processing information from field service engineers, sales representatives, and clinical facilities to obtain an understanding of alleged product malfunctions or serious adverse events. Navigate the complexities of government and industry regulations to include U.S. FDA 21 CFR 820, 21 CFR 803, 21 CFR 806, and ISO 13485 for adverse event reporting requirements. Coordinate Design Failure Mode and Effect Analysis (DFMEA), Hazard Analysis and Root-Cause analysis through failure analysis (FA) to launch Post market vigilance for new products. Utilize engineering skills of Design of Machine Components, Engineering Mechanics, Fluid Mechanics, Kinematics, Electrical and electronics and provide Engineering analysis on components mechanism & design for complaint investigation. Coordinate activities related to Corrective and Preventive Actions (CAPA), Field corrective Action (FCA), Issue Impact Assessment (IIA), Clinical Risk Assessment and Ensure compliance with ISO 14971 for complaint files and adverse event reporting requirements. Utilize statistical analysis tools like Shewhart, rank-based exponentially weighted moving average (REWMA), Change-point analysis, Poisson LRT to perform Complaint Monitoring, Signal Detection. Utilize Optimization Techniques & Operations management for process improvements. Utilize computer and software programs, database management, Business Objects like Global Complaint Handling (GCH), SAP production modules, Agile systems, Share Point, Box site. Utilize clinical and technical knowledge of Gastrointestinal and Lung Health & Visualization products including US Medical Device Reporting, EU Medical Device Vigilance, Manufacturers Incidents Reporting for EU, product recalls. Position may telecommute from anywhere in the United States.
Basic Qualifications:
Master's degree in Mechanical, Industrial, or Biomedical Engineering and two years of experience in quality engineering for medical devices. Must possess a minimum of two (2) years of experience with each of the following: Complaint handling for medical devices; FDA 21 CFR 820, 21 CFR 803, 21 CFR 806, and ISO 13485 for adverse event reporting requirements; ISO14971, Corrective and Preventive Actions (CAPA), Field corrective Action (FCA), Issue Impact Assessment (IIA), Clinical Risk Assessment, Design Failure Mode and Effect Analysis (DFMEA), Hazard analysis and Root-Cause analysis; design of machine components, Engineering Mechanics, Fluid Mechanics, Kinematics, Electrical and electronics; SAP production modules, Agile systems, Share Point, and Box site; statistical analysis and trending analysis of complaints; and Optimization Techniques and Operations. May telecommute from anywhere in the United States.