Senior Quality Engineer - Design Assurance, Limerick

We are the people who give possibilities purpose BD 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 Description About the role As Design assurance QE you will be involved in new product development and product sustaining projects through the application of Quality engineering skills. You will handle multiple projects and tasks, from product inception through product launch and maintenance utilising a high level of written and oral communication skills. You will play an active role in the processes to ensure products meet quality and compliance standards consistent with both Corporate and global standards and regulations while meeting all design controls, risk management, change control requirements, and other applicable regulatory requirements. The Design Assurance QE represents the Quality Function on Project core teams for both new product development and existing products. Main responsibilities will include: Be the Design Assurance Quality Engineer on project core teams for design change projects and develop close relationships with other quality functions as needed for the project. Write project quality plans and support the creation and maintenance of DHF documentation Lead risk management activities within the project. Support the creation and implementation of verification and validation activities Review and approve test protocol and reports. Review and challenge statistical rationale, and data analysis in the frame of test protocol and reports. Review and approve related execution deviations. Assist / conduct Failure investigations and problem-solving sessions Review quality objectives and goals that have been identified and ensure they are sufficiently defined in specifications, procedures, and testing. Conduct quality functional reviews and DHF compliance reviews. Ensure compliance across projects for design control, risk management, and change control processes. Support Quality culture within R&D organisation while providing training on applicable requirements / standards. About you A relevant degree (engineering degree- preferred) or equivalence of minimum 3 years of quality engineering experience Knowledge in working with ISO 13485, QSR, ISO 14971, statistical techniques Strong written and verbal communication skills Strong organisational skills Experience with MDR - advantage Experience with IEC 62304 and IEC 62366 - advantage Salary Range€55K - €70K Click on apply if this sounds like you! Why Join Us? To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future ofhealthcare. At BD, you'll discover a culture in which you can learn, grow and thrive. We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.TLNT1_IJ