Job Information
Danaher Corporation (Analyst, Quality Assurance II) 6 month contract in O'Callaghan Mills, Ireland
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 R&D Quality Assurance Analyst for Beckman Coulter Diagnostics is primarily responsible for supporting the risk activity, in addition to the Design Control Process, and provides the opportunity for exposure to both risk and design control processes. It's a critical role to our business as it ensures compliance of risk and design control activity.
This is a 6-month FTC role.
This position is part of the R&D Quality department located in Lismeehan, O’Callaghan’s Mills. Co. Clare and will be based onsite with flexibility to work from home. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.
You will be a part of the R&D Quality team and report to the R&D Quality Manager responsible for providing leadership, guidance and support to all areas in the design control and design change processes. If you thrive in a dynamic role and want to work to build a world-class quality organization—read on.
In this role, you will have the opportunity to:
Primarily update risk documents as part of FDA activity.
Support QA Design assurance activities in R&D, Supply chain, System integration, Packaging Development and Customer Support.
As assigned, act as quality representative on Design Change Projects and Innovation DP projects.
Review and approve validation protocols (including but not limited to equipment, utilities, processes, cleaning, test methods and software) and final validation reports ensuring compliance to all applicable procedures, work instructions and standards.
Solves problems in straightforward situations; analyses possible solutions using technical experience and judgment and precedents. Supports site CAPA and NC processes.
The essential requirements of the job include:
Bachelor's degree in relevant technical field with a minimum of 2 years' experience in a highly regulated (FDA desirable) healthcare or related environment OR Master's degree with 0-2years' experience in a highly regulated (FDA desirable) healthcare or related environment with a Bachelor's degree in relevant technical field
Excellent interpersonal/communication skills.
Excellent planning and organisational skills
It would be a plus if you also possess previous experience in:
IVDDs and/or Risk Management and/or Design Controls
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 www.danaher.com.
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.