Sr. Manager, Quality Compliance
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: The Senior Manager, Quality Compliance, provides operational leadership for Quality Compliance activities at Healthmark Industries within the Surgical Workflows – Infection Control Consumables (SWICC) business, ensuring regulatory and quality system compliance for U.S. FDA Class I and II medical devices, EU MDR Class I and Class IIa/IIb devices, and similarly classified products globally. Job Responsibilities and Essential Duties: Develops and manages the department to assess and ensure compliance with - FDA Quality System Management Regulations (QMSR) CFR Part 820, - ISO 13485:2016 (Medical Device QMS Standard), - ISO 9001:2015 (Quality Management Systems, Requirements) - EU Medical Device Regulation (MDR), (Regulation (EU) 2017/745), - Health Canada-Canada Medic...