Specialist II, Product Surveillance

• Interfaces with all levels of health care professionals (doctors, nurses, biomedical technicians and purchasing agents, materials managers and risk managers) to document, investigate, and correct field-related problems.
• Manage, maintain, and track customer complaints through the Quality Systems Database in accordance with Site procedures and regulatory agencies, specifically, 21 CFR Part 820, Complaint Files, and 21 CFR Part 803, Medical Device Reporting
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Communicates customer concerns and complaints to individuals who manage databases and analyze data to identify trends, needs for product and service enhancements and communicate the findings with relevant individuals such as R&D engineers, business unit managers, and other personnel to communicate the findings.
• Strong multitasking skills. Performs product complaint documentation, investigation, customer response, and consulting activities on company products and authors correspondence to customers addressing complaint investigations.
• Serves as a liaison between other business units for quality and technical concerns as needed.

Abbott