Senior R&D Quality Analyst - Permanent

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 Senior R&D Quality Analyst (Senior Analyst, Quality Assurance) for Beckman Coulter Diagnostics is responsible for supporting the Design Control Process, and acts as quality representative on Design Change Projects and Innovation DP projects with a specific focus on supporting the Clare site operations roadmap. It's a critical role to our business as it's responsible for reviewing design projects at each phase of the Design Control process for compliance. In this senior role, you will guide, mentor and support less experienced colleagues on the Design Control process.

This is a permanent role.

This position is part of the R&D Quality department located in Lismeehan, O’Callaghan’s Mills. Co. Clare and will be an on-site position. 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 Lead 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:

• Be responsible for the support of the Design Control Process, including design change, within all areas in BCII.
• Act as quality representative on Design Change Projects and Innovation DP projects with particular focus on supporting Clare site operations roadmap.
• Review design projects at each phase of the Design Control process for compliance and ensure compliant closure of Design History Files (DHFs).
• Support Tech Ops, Operations, R&D, System integration, Packaging Development and Customer Support from a QA perspective.
• 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.
•  Act as a resource for colleagues with less experience and provides training to staff on the specific requirements of the Design Control process in BCII and regulatory or standard requirements.
• As required conduct internal audits to ensure compliance of R&D and other technical areas as appropriate (System Integration, Packaging Development and Customer Support) with ISO13485 and FDA quality requirements.

The essential requirements of the job include:

• Bachelor’s degree (Honour’s Level 8) in chemistry, biochemistry, biology or other relevant technical field with a minimum of 5 years’ experience in a highly regulated (FDA desirable) healthcare or related environment.
• Strong team player with the ability to identify and drive quality improvements.
• Excellent planning and organisational skills

It would be a plus if you also possess previous experience in:

• IVDDs and/or Design Controls and/or Risk Management
• Auditing and certified auditor process

Join our winning team today. Together, we’ll 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.

For more information, visit www.danaher.com.

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