Wondering whats within Beckman Coulter Diagnostics? Take a closer look. At first glance, youll see that for more than 80 years weve 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. Were building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and youll 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, were working at the pace of change to improve patient lives with diagnostic tools that address the worlds biggest health challenges. The Manufacturing Quality Engineerfor Beckman Coulter Diagnostics is responsible for ensuring Quality Project deliverables are achieved, coordinating the creation, review and approval of non-conformances, Equipment Change Controls, Manufacturing Documentation in support of the Quality Management System. Responsibilities also include the review and approval of Process Validation Documentation ensuring compliance to Quality and Regulatory Standards and provide Quality expertise during investigations, process FMEAs and daily manufacturing issues driving process improvements. This position is part of the R&D QA department located in Co. Clare, Ireland and will have flexibility to work from homewhich will be Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time. This is an 8-month FTC. You will be a part of the R&D QA Team and report to the Blood Virus Quality Manager responsible for supporting cross functional teams providing Quality guidance and support to all departments ensuring Good Manufacturing Practices and Quality Systems Regulations are complied with during manufacture. You will act as a resource for colleagues with less experience and utilise best practices and skills to improve products and services. You will be part of a team that develops strong, positive and beneficial working relationships and effective information flow with other departments and within the Project team and Quality department. If you thrive in a multifunctional and fast paced role and want to work to build a world-class Quality organizationread on. In this role, you will have the opportunity to: Be responsible for the support of the New Product Development Process including design change, within all areas in BCII. Review and approve validation protocols (equipment, utilities, processes, cleaning, test methods and software) and final validation reports ensuring compliance to all applicable procedures, work instructions and standards. Co-ordinate the Non-conformance processes (NCs) for New Product Development areas ensuring compliance to Quality and Regulatory Standards. Perform CAPA (corrective and preventive action) activities and document in the Global CAPA system (Smartsolve) if required. Support creation, review and approval of Equipment and Manufacturing documentation. Initiate/review/approve document Change Controls (CCFs) and Equipment Change Controls (ECCs) ensuring Good Manufacturing Practices are maintained and comply with company procedures to support Project Deliverables. Review and approval/release of Batch History Records. Analyze and report meaningful quality metrics to ensure on-going improvement programmes are put in place and continually strive for customer satisfaction. Represent Quality at both internal and external audits. The essential requirements of the job include: Bachelors degree (Honours Level 8) in chemistry, biochemistry, biology or other relevant technical field with a minimum of 2 years relevant experience in a highly regulated healthcare or related environment. Strong team player with the ability to identify and drive quality improvements. Be competent in working independently. Excellent planning and organisational skills with the capacity to rapidly switch between tasks at ease. It would be a plus if you also possess previous experience in: FDA regulated environment Manufacturing background and Design Change Auditing and certified auditor process Risk Management At Beckman Coulter Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. Explore the flexibility and challenge that working for Beckman Coulter Diagnostics can provide. Skills: Validations Documentation Review Deviations Non Conformances Benefits: Medical Aid / Health Care Pension Fund Performance Bonus
