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Danaher Corporation

Quality Assurance Scientist-India

Posted 13 Hours Ago
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In-Office
8 Locations
Junior
In-Office
8 Locations
Junior
The Quality Assurance Scientist is responsible for ensuring compliance with quality standards and regulatory requirements, assisting in quality documentation, and supporting audits.
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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 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 Lismeehan, O'Callaghan's Mills, County Clare, Ireland and will be a remote role. 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

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. Check out our benefits at Danaher Benefits Info.

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.

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.

Top Skills

Fda 21 Cfr Part 820
Iso 13485
Microsoft 365

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