Quality Assurance Engineer

il y a 3 semaines

Marseille, France Beckman Coulter Life Sciences Temps plein

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

  • Quality Assurance Engineer

    il y a 3 semaines

    Marseille, Provence-Alpes-Côte d'Azur, France Danaher Temps plein

    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...

  • Quality Assurance Engineer

    il y a 2 semaines

    Marseille Cedex, France Danaher Corporation Temps plein

    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...

  • R&d Quality Engineer

    il y a 4 semaines

    Marseille, France Innate Pharma Temps plein

    Innate Pharma S.A. is a global, clinical-stage oncology-focused biotech company dedicated to improving treatment and clinical outcomes for patients through therapeutic antibodies that harness the immune system to fight cancer._ **Overall Objectives & Purpose of the role**: Within the Compliance & Operations division, and working with the Quality & GxP...

  • Quality Assurance Director

    il y a 1 semaine

    Marseille, France Volta Medical Temps plein

    **Who are we ?** Improving the lives of patients suffering from Atrial Fibrillation (a pathology causing an irregular heart rate) thanks to artificial intelligence ? It is possible ! The creation of Volta Medical follows the discovery of a new complex medical procedure to treat atrial fibrillation (the most common cardiac arrhythmia in the world) by the...

  • Regional Construction Quality

    il y a 4 semaines

    Marseille, France Vestas Temps plein

    **Location: France (Paris, Montpellier or Reims)** **Manufacturing and Global Procurement < COO MED < Regional Sales Quality MED** Regional Construction Quality will be an integral part of the Regional Quality, COO and Construction Leadership team and will bring sustainable Change in the business. Shall combine technical knowledge with people, process, and...

  • Project Engineer France

    il y a 1 mois

    Marseille, France Radio Holland Group Temps plein

    The purpose of your job is to convert commercial proposals into detailed technical proposals to be used in project implementation. Guiding the project team and project stakeholders in the technical execution of a project and supporting sales on complex proposals. In your role you are responsible for technically supervising various projects in the field of...

  • Quality Process Engineering Manager

    il y a 1 semaine

    Marseille, France airbus Temps plein

    Job Description: Airbus Helicopters is looking for a Quality Process Engineering Manager - DDMS (f/m) to join our “Aviation Safety & Quality Digital Operational Solutions” department based in Marignane, France.In particular, you will be responsible for representing the Airbus Helicopters Quality function at the Airbus group level for the DDMS (Digital...

  • Quality Manager Training

    il y a 1 mois

    Marseille, France AIRBUS HELICOPTERS SAS Temps plein

    Airbus Helicopters SAS recrute: **Description de l'emploi**: **Airbus Helicopters** recherche un **Quality manager training **(f/h) pour rejoindre notre Training Quality Customer Support & Services basé à Marignane, France. Vous ferez partie d'une équipe qui est en charge de la Qualité et de la conformité des activités de formation des clients...

  • Installation Engineer

    il y a 1 mois

    Marseille, France Bourbon Temps plein

    Bourbon Subsea Services est la société BOURBON dédiée aux opérations sous-marines offshore. De l'affrètement de navires aux projets clé en main, nos équipages offrent à nos clients une gamme complète de services pour les assister à toutes les étapes de la vie de leur champ pétrolier, depuis les phases de prospection et d'exploration, pendant la...

  • #es Logistics Quality Manager

    il y a 4 semaines

    Marseille, France Airbus Helicopters SAS Temps plein

    Entreprise : Airbus Helicopters SAS - Localisation : Marseille - France - Provence-Alpes-Côte d’Azur - Fonction : #ES Logistics Quality Manager - Type de contrat : Contrat à durée indéterminée (CDI) - Date de publication : 04-02-2023 **Description du poste**: **Description de l'emploi**: Airbus Helicopters recherche un R**esponsable Assurance...

  • #es Logistics Quality Manager Aog

    il y a 4 semaines

    Marseille, France Airbus Helicopters SAS Temps plein

    Entreprise : Airbus Helicopters SAS - Localisation : Marseille - France - Provence-Alpes-Côte d’Azur - Fonction : #ES Logistics Quality Manager AOG - Type de contrat : Contrat à durée indéterminée (CDI) - Date de publication : 04-03-2023 **Description du poste**: **Description de l'emploi**: **Airbus Helicopters **recherche un **R**esponsable...

  • Test Engineer

    il y a 1 mois

    Marseille, France ViVitro Labs Temps plein

    We have a new opportunity for a **Test Engineer** to join the growing team at **ViVitro Labs**, an internationally recognized and growing company. ViVitro Labs is a Canadian company specializing in cardiovascular device test equipment and contract testing services and is the only company in this space with two ISO 17025 accredited laboratories that offer an...

  • Qhse Engineer

    il y a 5 jours

    Marseille, France DEME Group Temps plein

    **QHSE engineer** At DEME, we work together on the cutting edge of technology in a challenging and rapidly changing world. Through our activities in the dredging, off-shore, infrastructure and environmental sectors, we work to bring tailor made solutions to our customers’ projects helping them to be safer, more cost effective and sustainable. Now you can...

  • Quality Mgr Ii

    il y a 1 mois

    Marseille, France Bio-Rad Laboratories Temps plein

    Présentation: Vous souhaitez mettre votre énergie au service d’une entreprise qui favorisent la découverte et contribuent à améliorer la vie des patients ? Vous voulez rejoindre une entreprise d’envergure internationale ? Devenez notre Responsable Qualité pour soutenir la croissance et le succès du site de Gemenos. Rattaché(e) à la Directrice...

  • Quality/security Engineer

    il y a 1 mois

    Marseille, France Thales Temps plein

    **QUI SOMMES-NOUS ?** Les entreprises et les gouvernements comptent sur Thales pour apporter de la confiance aux milliards d’interactions numériques qu’ils établissent avec les utilisateurs. L’Activité Mondiale Identité & Sécurité Numériques (DIS) fournit des technologies et services (des logiciels sécurisés en passant par la biométrie ou...

  • Field Service Engineer

    il y a 1 mois

    Marseille, France Advanced Sterilization Products Temps plein

    **Role**: This is an extraordinary career opportunity for a talented Field Service Engineer, which will enable you to develop customer satisfaction through the quality of the service provided. In this role, you would be ensuring technical interventions of preventive and curative maintenance for our devices across South of France and you will be reporting...

  • Subsea Projects Engineer

    il y a 4 semaines

    Marseille, France Bourbon Temps plein

    Bourbon Subsea Services est la société BOURBON dédiée aux opérations sous-marines offshore. De l'affrètement de navires aux projets clé en main, nos équipages offrent à nos clients une gamme complète de services pour les assister à toutes les étapes de la vie de leur champ pétrolier, depuis les phases de prospection et d'exploration, pendant la...

  • Senior Engineer Analog and Mixed-signal Design

    il y a 1 mois

    Marseille, France Infineon Technologies Temps plein

    In the role of Senior Engineer for Analog and Mixed-Signal Design, your primary responsibility will be to create power integrated circuits (ICs) and, specifically, intelligent switches designed for the automotive industry. You will join a talented team and collaborate closely with various other teams within the Research and Development (R&D) department. In...

  • Subsea Projects Engineer H/F

    il y a 1 mois

    Marseille, France BOURBON Temps plein

    Description du poste Intitulé du poste Subsea Projects Engineer H/F Contrat CDI Rôles et responsabilités MISSION •Responsible for engineering deliverables related to structural designs including proposal, specifications, reports, studies, R&D, installation procedures, and offshore follow up. When assigned to a project,...

  • R&d Hvac

    il y a 1 mois

    Marseille, France CMACGM Temps plein

    Led by Rodolphe Saadé, the CMA CGM Group, a global leader in shipping and logistics, serves more than 420 ports around the world on five continents. With its subsidiary CEVA Logistics, a world leader in logistics, and its air freight division CMA CGM AIR CARGO, the CMA CGM Group is continually innovating to offer its customers a complete and increasingly...