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This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare. Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission. About Us: Baxter's Mission At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare. Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission. Your Role at Baxter This is where you address challenges to save and sustain lives! The Post Market Surveillance Quality Associate II is responsible for processing high risk complaint files as well as providing Quality support and oversight. This position also serves as subject matter authority for Post Market surveillance complaint handling process for all US products. Your Team at BaxterWithin Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation. What you'll be doingServe as a subject matter authority for Post Market surveillance processes such as complaint handling or Regulatory Reporting Assisting in handling daily work assignments and workflows, identifying and raising issues Analyzing Post Market surveillance complaint information to identify issues or improvement opportunities Leading and/or participating in cross functional continuous improvement activities and projects, including NCRs/CAPAs Intake of incoming customer calls, and opening complaints from those calls Triaging of the Global Corporate Complaints Mailbox Timely and accurate processing and disposition of incoming customers’ emails What you'll bringBachelor’s degree (life sciences preferred) 2+ years relevant work experience in cGMP related industry or in a clinical setting. Experience with driving process improvement initiatives and projects preferred Application of lean principles preferred Proven knowledge of the FDA Quality System and Regulatory Reporting regulations (21 CFR 803, 806, 820, and 211) Strong customer facing communication with ability to lead people and encourage teamwork Ability to drive decisions quickly and effectively Excellent written/verbal communication and organizational skills Ability to make independent decisions with minimum oversight and ability to work independently Strong problem solving, critical thinking and analytical skills