Offers “Sanofi”

Expires soon Sanofi

Quality Engineer - Device Development (M/F)

  • Internship
  • Le Trait (Seine-Maritime)
  • Community management

Job description



​Le site du Trait en Normandie produit des seringues pré-remplies de médicament à destination d’un large public. Notre ambition est de renforcer notre position d’usine injectable faisant partie des plus performantes d’Europe de l’Ouest.

Le site a concrétisé sa démarche de diversification en relevant le défi du lancement de 3 nouveaux produits injectables issus de la biotechnologie.

Les pathologies que nous traitons ?  Les thromboses veineuses, phlébites et l’infarctus du myocarde.

Le poste peut aussi être basé sur le site Sanofi de Gentilly (CSVB) avec des déplacements réguliers sur le site du Trait

Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l'international, l'anglais étant la langue de travail

ROLE DESCRIPTION – Quality Engineer (device development)

Quality Engineer overseeing all Quality work stream activities for Medical Device and Drug Device Combination product developments; responsible for ensuring all development activities are carried out in compliance with internal and external regulations (e.g. Design Controls) with fully compliant and auditable design history files; responsible for end-to-end Quality activities to ensure best product Quality .

ROLE PURPOSE

The role is created to support the development of the Sanofi Medical Device and Drug Device Combination product pipeline focused on Quality compliance and product Quality.

SCOPE

The scope will cover all aspects of Quality & Risk Management work steam activities within the development of Medical Device and Drug Device Combination products

PRINCIPAL ACCOUNTABILITIES

·  Assure all design and development activities are in compliance with Design Controls and the relevant elements of the Quality System Regulations for Medical Device and Drug Device Combination products.
·  Ensure the implementation and application of the Device Risk Management in accordance with the ISO14971
·  Work with cross-functional development teams to assist in the development of engineering studies, design verification protocols (incl. aging), and validation protocols, ensuring appropriate selection of acceptance criteria and sampling plans.
·  Participate in design reviews and provide expert technical Quality & Risk Management input to ensure potential problems are identified and corrected early in development
·  Oversee assembly process development and design transfer activities to ensure that product design has been appropriately translated into production specifications.
·  Assist in the development of validation strategies for performance qualifications and process validations for Medical Device and Drug Device Combination products.
·  Review and approval of development documentation.
·  Support/ lead root cause investigations and implementation of corrective actions
·  Provide expert Quality input for proposed design and/or process changes with respect to impact assessment.
·  Provide expert Quality input and participate in supplier, customer, internal and/or regulatory agency audits.

REPORTING STRUCTURE 

The Quality Engineer for Medical Device and Drug Device Combination product developments has a solid line reporting into the MED Quality Operations Manager based at Le Trait site.

REQUIREMENTS / COMPETENCIES

Experience:

·  M.Sc. or equivalent degree in Engineering or related scientific discipline.
·  3-5 years in functions related to quality, engineering, or development of Medical Devices and/ or Drug Device Combination products.
·  Exposure to multiple functions across R&D and the Industrial Operations network

Competencies:

·  Demonstrated knowledge in quality and design development systems:
·  Implementation of GxP practices applicable to parenteral products development
·  Implementation of Medical Device design and development (ISO13485, 21 CFR 820, …)
·  Experience in Medical Devices and/ or Drug Device Combination product development
·  Ability to operate in an international, cross-company and cross-functional environment. - Professionalism and demonstrates solidarity with organization and team members. - Communication and inter-personal skills necessary to build trust, confidence, and collaboration toward shared objectives. - Creativity and common sense.
·  Language - Good communication skills (written and oral) - Written and oral fluency in English is required.

Chez Sanofi, la diversité et l’inclusion sont au cœur de notre fonctionnement et sont intégrées à nos Valeurs fondamentales. Nous sommes conscients que pour exploiter véritablement la richesse que la diversité nous apporte, nous devons faire preuve d'inclusion et créer un environnement de travail où ces différences peuvent s'épanouir et être développées pour améliorer le quotidien de nos collègues, patients et clients. Nous respectons et valorisons la diversité de nos collaborateurs, leurs parcours et leurs expériences dans un objectif d’égalité des chances pour tous. Dans le cadre de son engagement diversité, Sanofi accueille et intègre des collaborateurs en situation de handicap.

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

As part of its diversity commitment, Sanofi is welcoming and integrating people with disabilities.

Make every future a success.
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