Manager Quality Compliance - Wayne, NJ

Job description

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview: The Manager, Quality Compliance is responsible for leading the Cardiac Surgery/Vascular Intervention Quality Compliance group. This position will have a responsibility for providing support for maintenance of quality systems, Internal audit program, CAPA process, management of 3rd party audits (FDA, ISO, other), FDA inspection response to 483 observations and periodic updates. This position partners with Quality leaders as well as representatives/leaders from the other cross functional groups on Quality Management System improvements. Develops and manages the department to assess and ensure compliance to the FDA QMSR (Quality Management System Regulations Part 820), ISO 13485 Quality System Standard, MDD, CMDR, WHLW, ANVISA, JPAL and other applicable regulations....