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 the Chemistry product line.
This position is part of the Complaint Handling Unit located in Lismeehan, 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.
In this role, you will have the opportunity to:
* Ensure records are correctly classified, populated per the current procedures and policies and investigated 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.
* Escalate product issues to senior/ executive management. Recommend appropriate actions to product regulatory committees including assessment for PLRA and Stop Ship.
* Represent 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 in Science or Engineering related discipline
* 0-2 years' experience in a Laboratory Environment, Technical Field (Science or Engineering) and/or Compliance (Complaints, Quality or Regulatory).
* Good Troubleshooting skills
* Good Knowledge of FDA QSR and ISO 13485 requirements
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.
* Basic understanding and/or experience running the AU chemistry analyzer.
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.
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