Quality Assurance Engineer
Il y a 7 mois
Beckman Coulter Life Sciences’ mission is to empower those seeking answers to life’s most important scientific and healthcare questions. With a legacy spanning 80+ years, we have long been a trusted partner to our customers, who are working to transform science and healthcare with the next groundbreaking discovery. As part of our team of more than 2,900 associates across 130 countries, you’ll help drive our vision of accelerating answers—and our commitment to excellence.
Beckman Coulter Life Sciences is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.
We are currently seeking a Quality Assurance Engineer who will be responsible for ensuring compliance of the documentation and process related to the design control process.
Within the Quality Assurance/Regulatory Affairs team and in accordance with the quality policy, you guide the development teams in organizing projects in compliance with international standards and regulations applicable to in vitro diagnostic medical devices.
You are responsible, independently from other departments, for ensuring compliance of the documentation and process related to the design control process. You collaborate with the registration team to facilitate and start this process You participate in the implementation and monitoring of Quality indicators associated with your activity. In direct collaboration with the R&D team, you ensure the follow-up of updates to this documentation.
LI-hybrid
**In this role, you will be responsible for**:
- Lead design control of flow cytometry reagents from a QSM stand point
- Ensure compliance with good documentation practices
- Follow up and organize the necessary reviews with the various stakeholders (Engineering, R&D, Manufacturing, Quality Control, Registration Team).
- Propose solutions to improve processes and product quality.
**The required qualifications for the job include**:
- Master’s degree in science, medical, or equivalent or PhD with at least 5 years of experience on design control or similar position.
- Experience working with medical device quality systems in compliance with US FDA regulations (21 CFR), ISO 13485 and IVDR EU 2017/746, ISO 9001.
- In Vitro Diagnostics (IVD) experience including medical device development
At Beckman Coulter Life Sciences we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter Life Sciences can provide.
La mission de Beckman Coulter Life Sciences est de donner à ceux qui cherchent des réponses à leurs questions les questions scientifiques et de santé les plus importantes de la vie. Avec un héritage s’étendant sur 80+ ans, nous sommes depuis longtemps un partenaire de confiance pour nos clients, qui s’efforcent de
Transformez la science et les soins de santé grâce à la prochaine découverte révolutionnaire. Dans le cadre de notre équipe de plus de 2 900 associés répartis dans 130 pays, vous contribuerez à la réalisation de notre vision
d’accélérer les réponses et notre engagement envers l’excellence.
Beckman Coulter Life Sciences est l’une des 10 sociétés de sciences de la vie de Danaher. Ensemble, nous accélérons la découverte, le développement et la mise en œuvre de solutions qui protègent et améliorent la santé humaine.
Nous sommes actuellement à la recherche d’un/une Ingénieur Assurance Qualité qui sera responsable d’assurer la conformité de la documentation et du processus liés au processus de contrôle de la conception.
Au sein de l’équipe Assurance Qualité/Affaires Réglementaires et dans le respect de la politique qualité, vous accompagnez les équipes de développement dans l’organisation de projets dans le respect des normes et réglementations internationales applicables aux dispositifs médicaux de diagnostic in vitro.
Vous êtes responsable, indépendamment des autres départements, de veiller à la conformité de la documentation et du processus liés au processus de contrôle de la conception. Vous collaborez avec l’équipe d’inscription pour faciliter et démarrer ce processus Vous participez à la mise en place et au suivi des indicateurs Qualité associés à votre activité. En collaboration directe avec l’équipe R&D, vous assurez le suivi des mises à jour de cette documentation.
**Dans ce rôle, vous aurez l’occasion de**:
- Assurer le contrôle de la conception des réact
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