Quality Assurance Scientist (d/f/m)

Descrizione del lavoro:

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 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 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.

The essential requirements of the job 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 preferred.
* Knowledge in medical technology/clinical laboratory preferred.
Vous souhaitez rejoindre une organisation engagée dans l'excellence opérationnelle et l'amélioration continue ?

Au sein de la Complaint Handling Unit, vous contribuerez à la gestion des réclamations clients pour garantir la conformité des produits et des processus. Vous réaliserez des investigations, participerez à l'analyse des tendances et apporterez votre soutien aux activités qualité dans un environnement international.

Dans ce rôle, vous serez amené(e) à :
* Réaliser des investigations scientifiques (analyse des données, tests en laboratoire).
* Traiter les réclamations conformément aux procédures internes et aux normes internationales.
* Participer à l'évaluation des risques et soumettre les cas pertinents au processus CAPA/ACAP.
* Contribuer au processus de Stop Ship lorsque requis par la réglementation.
* Rédiger la documentation qualité, y compris les rapports destinés aux autorités (ANSM, FDA).
* Suivre et interpréter les tendances liées aux réclamations.
* Collaborer avec les équipes locales et globales sur les projets et initiatives d'amélioration.

Les exigences essentielles pour ce poste sont les suivantes :
* Formation : Bac +5 en Sciences de la vie (biologie, biotechnologie, biochimie, chimie ou équivalent).
* Capacité d'analyse et de résolution de problèmes.
* Compétences en communication écrite et orale ; documentation en anglais obligatoire.
* Esprit d'équipe, rigueur et orientation qualité.
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Une expérience préalable dans les domaines suivants serait un atout :
* Connaissance des exigences qualité et réglementaires (FDA QSR, ISO 13485…).
* Expérience en gestion de réclamations, laboratoire, post-market surveillance ou qualité.
* Connaissances en technologie médicale ou laboratoire clinique.
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