Quality Assurance Scientist I

Wondering what's inside Beckman Coulter Diagnostics? Take a closer look. At first glance, you'll see that for over 80 years, we have been dedicated to advancing and optimizing the laboratory to advance science and healthcare. Join a team where you can be heard, be supported, and always be yourself. We are building a culture that celebrates the backgrounds, experiences, and perspectives of all our associates. Look again and you'll see that we invest in you, offering you the opportunity to build a meaningful career, be creative, and try new things with the support you need to succeed. Beckman Coulter Diagnostics is proud to work alongside a community of six other diagnostic companies at Danaher. Together, we work 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 Immunoassay product line. This position is part of the Complaint Management Unit located in Marseille, France or Clare, Ireland and will be on-site. You will be part of the Post-Market Surveillance organization and report to the Post-Market Quality Assurance Manager responsible for ensuring complaints are properly classified, records are completed in accordance with current procedures and policies, and 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 properly classified, completed in accordance with current procedures and policies, and thoroughly investigated. • Design and conduct investigations on records deemed appropriate/necessary. • Perform reviews of customer complaint records to determine CAPA eligibility. Draft CAPA requests if necessary. Escalate product issues to senior/executive management. Recommend appropriate actions to product regulatory committees, including evaluation for PLRA and Stop Ship. • Represent QA on product development, current business, or product improvements through projects, kaizens, CAPA, and department initiatives. Essential requirements for the position include: • Bachelor's degree in Science or Engineering in a related discipline 0-2 years of 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 have: • Experience in complaint investigation or post-market/QA surveillance desirable but not essential • Knowledge in medical technology/clinical laboratory desirable but not essential. 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.