BD (Becton, Dickinson and Company) 质量工程师_R&D_苏州 in Shanghai, China
Job Description Summary
Performs quality assurance activities to ensure compliance with applicable medical device regulatory requirements. Contributes to the completion of specific programs and projects usually under the direction of a project leader. Good understanding and frequent application of quality assurance principles, concepts, industry practices, and standards. Works under general direction while independently determining and developing approaches to solutions. Frequent inter-organization and limited outside customer contacts.
Able to comprehend Quality System requirements; plan, prepare and execute systems to ensure compliance with QSR, ISO, and EN requirements.
Review and improve existing quality procedure workflows and identify areas of improvement for efficiency.
Conduct quality audits at own and vendor locations to assess compliance to applicable standards and regulations; prepare and execute action plans to improve overall compliance.
Independently author concise quality investigation reports with appropriate corrective action and preventive actions (CAPA)
Review new and modified product design specifications including product performance specifications, test methods, acceptance criteria, and release to manufacturing.
Understanding and coaching others on Quality Systems and procedures.
Contribute as a team member on development projects carrying out assigned quality assurance responsibilities in a timely, diligent, safe, and professional manner.
Contribute to development and maintenance of Design History Files in a manner consistent with regulatory requirements.
Provide quality-related inputs to projects on product reliability, in meeting quality deliverables.
Guide the development of quality plans, execute inspection & testing activities and work further with Manufacturing on the transfer of quality requirements.
Provide statistical inputs on product testing and control of quality characteristics.
Support R&D in device product/process development and production activities.
Perform trend analysis, risk management (such as FMEA, Hazard Analysis, Fault Tree) and six sigma tools
Primary Work Location
CHN Shanghai - HQ
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.