Design Quality Assurance Engineer (Remote)

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: As a Design Quality Assurance Engineer, you will play a key role in ensuring that new product design and design changes across Getinge’s Infection Control Consumables portfolio meet applicable quality and regulatory requirements. This includes FDA Class I and II medical devices, EU MDR Class I devices, and selected non-regulated products. You will work cross-functionally with Regulatory Affairs, R&D, Manufacturing, and Operations to support compliant product lifecycle management and change execution, with a strong focus on regulatory impact assessment and design change governance within the Arena PLM system. Job Responsibilities and Essential Duties: - Support and govern design and design change activities in accordance with FDA Quality System requirements (21 CFR...