Quality Assurance Science II

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 investigating customer complaints for multiple product lines.

This position is part of the Complaint Handling Unit located in County Clare Ireland and will be on-site. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.

You will be a part of the Post Market Surveillance organization and report to the Post Market Quality Assurance Manager responsible for ensuring complaints are correctly classified, records are populated per the current procedures and policies, and are investigated in a timely manner. If you thrive in a multifunctional role and want to work to build a world-class post market surveillance organization—read on.

In this role, you will have the opportunity to:

• Ensure records are correctly classified.
• Ensure records are populated per the current procedures and policies.
• Investigate the record thoroughly.
• Design and perform investigations into the records as deemed appropriate/ necessary.
• Conduct reviews of customer complaint records to determine CAPA eligibility. Author CAPA requests where necessary.
• Recommend appropriate field actions to product regulatory committees.
• Escalate product issues to senior/ executive management
• Complete Risk assessments where needed
• Assess for Stop Ship
• Exercise judgment within defined procedures and practices to determine appropriate actions.
• Represents QA on development, current business or product improvements through projects, kaizens, CAPA and department initiatives.

The essential requirements of the job include:

• Bachelor’s Degree
• Minimum of 2-year experience relevant Industry Experience
• Knowledge of domestic and international quality systems standards such as FDA 21 CFR Part 820 and ISO 13485
• Good Troubleshooting skills

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

• Experience in Complaint Investigation or Post Market Surveillance/QA preferred
• Medical Technology/Clinical Laboratory background preferred

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.