Quality Sustaining Engineer
Getinge · Fraser, Michigan, US
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...
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 Quality Sustaining Engineer, you will play a key role in ensuring that Healthmark product across Getinge’s Infection Control Consumables portfolio meet applicable quality 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 on Healthmark products for design transfer deliverables and resulting acceptance activities and production and process controls for both Healthmark designed and distributed products. Job Responsibilities and Essential Duties: - Support design change transfer deliverables and activities in accordance with FDA Quality System requi...