Quality Assurance Scientist I

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 Scientist I for Beckman Coulter Diagnostics is responsible for ensuring global service documentation outputs are meeting our quality and regulatory standards.

This position is part of the Post Market Surveillance department located in County Clare, Ireland and will be fully remote. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.

You will be a part of the global Service Quality Assurance team and report to the Senior Manager Quality Assurance responsible for ensuring Service quality and regulatory compliance. If you thrive in a multifunctional role and want to work to build a world-class service quality organization—read on.

In this role, you will have the opportunity to:

• Lead Daily Management meetings and maintain oversight over OUS service record reviewers to ensure service records generated by a global field service organization are meeting requirements.

• Clearly articulate record noncompliance to record originators to drive quick record corrections and promote a culture of continuous learning.

• Learn how to utilize Danaher Business Systems (DBS) tools to problem solve and actively participate in cross-functional DBS activities (including Kaizen) to drive continuous improvement.

• Assist in drafting Corrective Action and Preventive Action (CAPA) requests, as required, for Service nonconformances.

• Support department during internal and external audits by collecting, reviewing, and preparing service documentation for use in the audit front room.

The essential requirements of the job include:

• Bachelor’s Degree in a Science, Technology, Engineering or related field plus minimum 1 year of relevant industry experience

• Proficient in Microsoft 365 products – Word, Excel, PowerPoint, OneNote, etc.

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

• Domestic and international quality systems standards such as FDA 21 CFR Part 820 and ISO 13485

At Beckman Coulter Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote 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 www.danaher.com.

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