Senior Analyst Quality Assurance

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Beckman Coulter Diagnostics, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. 

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory’s role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making—we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence.

Learn about the Danaher Business System which makes everything possible.

The Senior Analyst R&D Quality Assurance for Beckman Coulter Diagnostics is primarily responsible for Clare site support and provides the opportunity for exposure to both risk and design control processes. It's a critical role to our business as it ensures business continuity and design control activity.

This is a 18 month Fixed Term Contract role

This position reports to the R&D Quality Manager and is part of the R&D Quality Team located in Clare and will be an on-site role.

In this role, you will have the opportunity to:

• Support QA Design assurance activities in Supply Chain, R&D, System integration, Packaging Development and Customer Support.

• Responsible for the support of the Design Control Process, including design change, within all areas of BCII,

• 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 & analyses possible solutions using technical experience and judgment and precedents. Supports site CAPA and NC processes.

• 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 regulations.

The essential requirements of the job include:

• Bachelor’s Degree with 5+ years’ experience, OR Master’s Degree with 3+ years, OR Doctoral Degree with 0–2 years highly regulated (FDA desirable) healthcare or related environment with a Bachelor's degree in relevant technical field

• Excellent interpersonal/communication skills.

• Excellent planning and organizational 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

Beckman Coulter Diagnostics, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job.

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.

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.