Abbott Laboratories - Alameda, CA
posted 4 months ago
As a Quality Systems Analyst II at Abbott, you will play a crucial role in the Diabetes Care division, which is dedicated to improving the lives of individuals with diabetes through innovative products that provide accurate data for better health management. This position is based in Alameda, CA, where you will be involved in various data analysis activities that are essential for maintaining high-quality standards in our products and services. Your primary responsibilities will include analyzing complaints and trending data related to Medical Device Reporting (MDR) and Medical Device Vigilance (MDV), as well as providing critical data inputs for Management Review and month-end reporting activities. In this role, you will serve as an internal liaison and expert for the Complaint Handling database, overseeing its development, maintenance, and sustainability. You will collaborate with cross-functional Quality and Business Unit Teams to meet reporting requirements, which encompass complaints trending and summaries, FDA Medical Device Reporting, EU Medical Device Vigilance reporting, and regular product line complaints reporting on a weekly, monthly, and quarterly basis. Your support will also extend to internal and external audits, where you will prepare and present relevant reports and analyses. You will be expected to comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, and company policies while maintaining positive and cooperative communication with employees, customers, contractors, and vendors at all levels. Additionally, you will be tasked with performing other related duties as assigned, contributing to the overall success of the Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory initiatives within the company.