We are the people who give possibilities purposeBD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

Job DescriptionJob Responsibilities:Act as the Quality core team member for sustaining engineering projects.Participate in design control activities, including design reviews, risk management, and verification and validation planning and execution.Support the development and maintenance of design and development files DDFs to ensure compliance with internal procedures and external regulations e.g., FDA, ISO 13485.Perform and/or review risk management activities, including Hazard Analysis, FMEA Failure Mode and Effects Analysis, and risk-benefit analysis, ensuring appropriate risk mitigation strategies are identified and implemented.Provide quality engineering support for CAPA activities, including performing investigations and implementation of actions, and executing verification of effectiveness VOE to ensure solutions are sustained and compliant with FDA/ISO and internal requirements.Author field issue assessments using post-market data, complaint investigations, and risk analyses in compliance with 21 CFR 806 and EU MDR.Participate in internal and external audits e.g., FDA, Notified Body.Mentor junior quality engineers and provide technical guidance on design quality principles and practices.Collaborate with cross-functional teams R&D, Manufacturing, Regulatory Affairs, Marketing to ensure quality objectives are met.Develop and implement quality plans, procedures, and work instructions to enhance the effectiveness of the quality management system.Contribute to con
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