Quality Systems Specialist
Be a key driver of cGMP practices within Operations and Quality divisions. Provide support for the ISO13485 and 21CFR Part 820 Quality Systems. Provide a quality review on a range of quality documentation including, SOPs, Policies, Guidelines, Specifications, Investigations, Complaints, Change Controls, GMP records and other Quality Management Systems Documentation as required. Responsible for ensuring adherence to internal and external regulatory requirements. Support of the PosiFlush batch release process and release function. Maintain quality content of PosiFlush PVD board. Ensure compliance of the Quality System with all applicable medical device regulations as well as the Medical Surgical and BD Corporate Quality System. Support Quality Engineering/Continuous Improvement activities as required. Support External Audits and closure of audit findings as required. About Us. BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health. This job originally appeared on RecruitIreland.com.
274 days ago