BD (Becton, Dickinson and Company) Section Manager, QMS _QA_苏州_SZP3 in Suzhou, China
Job Description Summary
Lead QMS team to ensure the plant quality system compliance and maintenance according to regulatory and corporate requirements.
Be responsible for maintaining Quality Management System to compliance to Medical Device regulations requirements (Include China Sterile Medical Device, ISO13485, FDA QSR 820, EUMDD/EUMDR etc.) and Corporate requirements
Responsible for plant Internal/external audits, including Internal/external audit planning, implementation, follow up the correction, corrective/ preventive actions as a result of the external audit and ensure on time closure to the audit findings.
Support the quality manager and management representative on the management review meeting arrangement, planning, implementation and follow up.
Lead site supplier quality management activities, work with procurement team on the supplier selection, responsible supplier quality risk level determination, supplier qualification, approval and ongoing maintenance management to the plant suppliers
Lead site document control process, make sure the document controlling fulfill medical device regulations and BD corporate requirements.
Lead site complaints handling process, work on the internal investigation, corrective action, follow up and external complaint handling communication with DCHU and RCC.
Primary Work Location
CHN Suzhou - Plant 3
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.