Quality Assurance Engineer - Quality Systems

Wondering what's within Beckman Coulter Diagnostics? Take a closer look.At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We're building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you'll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we're working at the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges. The Quality Assurance Engineer - Quality Systems for Beckman Coulter Diagnostics is responsible for supporting implementation and monitoring compliance to the Quality Management system for the site. This position is part of the QRC located in Beckman Coulter Ireland Inc. and will be hybrid (minimum 2 days onsite) At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.You will be a part of the Quality systems team and report to the Quality Systems Manager responsible for implementation of the Quality Management system with focus on CAPA process and Audit activities (internal and external). If you thrive in a compliance focused, cross functional, fast paced, supporting role and want to work to build a world-class Quality organization—read on.In this role, you will have the opportunity to:Provide site support on quality system issues to ensure adherence to applicable regulations, standard requirements, and industry best practice.Coordinate CAPA activity across the siteCoordinate and participate in internal and external audits at the siteTrack and trend data and prepare trend analysis on areas such as CAPA, Audits as required.Support planning and preparation activities associated with Beckman Coulter Ireland Inc. QSMRMaintenance of procedures necessary for the efficient operation of the quality systemComplete and coordinate Quality Planning activities at the siteProvide training, support and direction regarding QS requirementsThe essential requirements of the job include:Third level qualification in a Science/Engineering discipline and a minimum of 2 years' experience in a similar/related role is requiredOR Master's degree in Science/Engineering.A good working knowledge / understanding of ISO13485, FDA (CGMP), CMDR, MHLW, and IVDD/IVDR requirements.Intermediate working knowledge of Microsoft Office suiteIt would be a plus if you also possess previous experience in:Lead auditor trainingStatistical techniquesAt Beckman Coulter Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part of the time at the Company location identified above and part of the time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter Diagnostics can provide.At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit .At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.