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Quality Compliance Manager

Req # JR - 165191 Location Pluvigner, Brittany Region, France Job Category Quality Date posted 04/28/2025
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Overview

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

  • Support for Parents

  • Continuing Education/ Professional Development

  • Employee Heath & Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

Success Profile

What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

  • Detail Oriented
  • Continuous Learner
  • Courageous
  • Collaborative
  • Critical Thinker
  • Influential

Quality Compliance Manager

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This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Chez Baxter Healthcare Corporation, nous sommes engagés à sauver et préserver des vies grâce à des produits et services médicaux innovants. Notre équipe est passionnée de faire la différence et nous avons été reconnus comme un "Great Place to Work" pour la 7ème année consécutive. Rejoignez-nous dans notre mission et devenez partie prenante d'une industrie dynamique et en évolution.

Ce que vous ferez :

  • Gestion des audits

    • Participer aux audits externes : être référent pour les organismes de certification

    • Piloter les audits internes : organiser ces audits et coordonner les auditeurs

    • Suite aux audits, proposer les plans d’actions, contrôler leur réalisation et vérifier leur efficacité

    • Garantir la communication liée aux audits (préparation, résultats, …)

  • Pertinence, adéquation, efficacité et efficience du Système Qualité

    • Vérifier l’adéquation du SMQ avec l’évolution des exigences externes et internes, et avec les processus

    • Aider à la préparation des revues de direction et comités de pilotage

    • Participer à l’amélioration continue du SMQ

  • Gestion documentaire

    • Conseiller les services dans la mise en œuvre de leur organisation Qualité

    • Former les utilisateurs à l’outil de gestion du système documentaire

    • Assurer la vérification et l'approbation des documents et leur cohérence avec le Système Qualité

    • Participer à la traduction des documents applicables au site

  • Gestion des Actions Correctives & Préventives

    • Participer à la détection des écarts au SMQ

    • Former et conseiller les services dans l’application du processus CAPA

    • Gérer les indicateurs de gestion des CAPA

    • Être le référent du site pour les CAPA

  • Management du Service

    • Manager les ingénieurs et techniciens du service

    • Mener les entretiens de performance des subordonnés

    • Gérer le personnel et la permanence des missions du service (congés, remplacement)

    • Superviser les activités qualité de Master Validation Plan, IQ, OQ, and PQ des équipements et process.

  • Promotion – Formation

    • Promouvoir le SMQ

    • Former et conseiller les services dans l’application des nouvelles exigences

    • Développer & proposer les formations adéquates, afin d’accroître la compréhension et l’adhésion au SMQ

    • Suivi des indicateurs de formation du site.

Ce que vous apporterez :

  • Formation niveau Bac+5 en ingénierie, qualité ou équivalent.

  • Expérience professionnelle (l’un ou l’autre) :

    • 5 ans dans un milieu industriel rattaché aux plus grands référentiels qualité (Pharmaceutique, aéronautique, FDA, ISO 13485, …)

    • 2 ans dans un service qualité, intégré à une entreprise du milieu industriel des dispositifs médicaux

  • Management d’équipe

  • Maîtrise de l’anglais

  • Maîtrise des outils bureautiques, de gestion documentaire, analyse de données et tendances.

  • Esprit de synthèse

  • Maîtrise des référentiels Qualité applicables, ISO 13485, ISO 9001, FDA 21 CFR Part 820

  • Expérience dans la réglementation et Inspection FDA

  • Connaissance des principes de l’amélioration continue

  • Force de proposition

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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Address

Explore this location BP 14 Za du Talhouet
56330 Pluvigner
France Explore This Location

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Christelle, Senior Quality Manager in Malta

“I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need.”

Meet Lorena, Senior QA Associate in London, UK

“I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety.”

Meet Gary, Quality Research Manager in Singapore

“I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission.”

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