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Becton Dickinson
,
Reading, Berkshire
Quality Manager Risk Management
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Job Type: Full-time |
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Overview
BD is a global medical technology company focused on improving drug therapies, enhancing the quality and speed of diagnosing infectious diseases, and advancing research and discovery of new drugs and vaccines. BD provides an environment which enables our highly talented workforce to be the best at their professions. We are always seeking people who have a passion and commitment to join our Company on its journey to be a leader in 'advancing the world of health’ BD is recruiting a Quality Manager - Risk Management who will provide leadership of the Risk Management Function for infusion products . Through adequate communication, effective problem solving and active vigilance on applicable requirements, you will be accountable for the compliance of risk management activities related to new product introduction (NPI) and to product maintenance for the infusion pump business. You will also drive compliance and continuous improvement of risk management processes with the support of the Quality Engineering function. As Quality Manager - Risk Management, you will; Provide Risk Management technical expertise through the product life cycle (act as an SME in RM) Develop or remediate and maintain Risk Management Files according to ISO 14971 and MDR requirement Work with R&D and Sustained Engineering on the development and incorporation of Risk Management and compliance to standards during all design phases for new and/or product enhancements. Facilitate development and completion of risk assessments for field issues/complaints in the field. Work with all production and post-production functions (manufacturing, post market surveillance, complaints, CAPA, Corrections and Removals, Change Control, Supplier Quality, acceptance activities) to ensure the proper application, use and updates of risk management files. Work with Clinical personnel on creation of appropriate harm/hazard analysis for issues potentially impacting patient outcomes. Keep up to date on new regulations and standards that affect Risk Management for medical devices. Ensure Risk Management procedures, processes and files are updated where required. Train and develop Quality engineers to provide efficient support for execution of risk management activities in a harmonized manner as well as key stakeholders to improve the overall risk management process efficiency. Be the MMS OUS infusion representative for interaction with Global MMS Product risk management network. Monitor effectiveness of the product risk management process through the MMS OUS infusion platforms, Implement appropriate tools to manage the activity (IT tools, risk management tools) in collaboration with WW risk management associate director, Create, develop and promote an MMS OUS infusion product risk management network: The successful candidate will have an Engineering degree in a technical field with relevant experience in the medical device industry. You will have strong knowledge of Risk Management discipline and must be able to apply quality principles to the R&D environment. You will also have the following attributes: Demonstrate knowledge of risk management, regulatory and quality engineering policies, principles and best practices for medical devices Good understanding of Medical devices design and development requirements Strong analytical, technical and problem-solving skills, Rigor and good organization, pragmatic The ability to make timely critical decisions regarding product risks and compliance. The capacity to engage and deliver on objectives and expectations. Proven track record of initiating and driving continuous improvements. Must have proven leadership, communication, organization and project management skills. The ability to communicate efficiently to MMS leadership team, internal customers and key stakeholders and influence. If you’re a team player who is passionate about manufacturing and 'advancing the world of health’ and we’ve just described your career aspirations, then please click on the APPLY button where you will be directed to our website to apply directly. Interested in a career with BD, but this position doesn’t fit your skills and experience? Join our external EMEA Talent Community here: http://bd.tal3nt.community/