À propos de nous

Unilabs est l'une des principales entreprises de diagnostic en Europe et propose aux patients, sur quatre continents, une offre complète de services de laboratoire, de pathologie et d'imagerie. En tant que leader du numérique couvrant l'ensemble du domaine du diagnostic, les plus de 13'000 collaborateurs d'Unilabs dans le monde sauvent des vies chaque jour. Unilabs investit massivement dans la technologie, l'équipement et le personnel et utilise les technologies numériques de pointe dans ses laboratoires et instituts d'imagerie pour améliorer la vie de près de 100 millions de personnes chaque année.

Vos responsabilités

  • Promote and embody the company vision and policies while maintaining the genetic laboratory’s licensure and accreditations. Manage and enhance the Quality Management System (QMS) in compliance with ISO 15189, ISO 17025, IVDR, and company standards, assisting with quality-related issues and fostering a culture of quality through education.

  • Communicate significant changes affecting laboratory capabilities to accreditation bodies, and prepare accreditation dossiers while accompanying auditors and coordinating responses to findings. Identify and document non-conformances, assess risks, and conduct root cause analyses, reporting trends at quality meetings.

  • Oversee post-market incident activities, drive continuous improvement through monitoring indicators and corrective actions, and organize annual Quality Management Review meetings with relevant teams. Ensure compliance of in-house devices with IVDR requirements, collaborate with procurement on supplier compliance, and implement risk management procedures.

  • Represent the Quality and Regulatory functions during M&A due diligence and integration processes, and participate in crisis management to ensure business continuity while performing other assigned duties as needed.

Compétences requises

Education and Experience
  • Bachelor’s degree or master’s degree in a technical/ process engineering/QA discipline, with significant related professional experience within the laboratory environment.
  • Prior in-depth experience working in an ISO 15189 accredited diagnostic laboratory with a focus on Quality Management Systems.
  • Ideally experience with medical device regulation and/or in-vitro diagnostic directive regulation.
  • 3 years of People Leadership Operations experience, preferred.
  • Fluent in French and English, German is a plus
  • Minimum Years Recommended and/or Preferred: 8-10 years

Required skills
  • Excellent interpersonal, organizational & communication skills with excellent attention to detail.
  • Self-motivated and driven critical thinker able to work in high pace and rapidly changing environment.
  • Responsive problem solver and action oriented.
  • Ability to affect change.
  • Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions.

Nous offrons

  • Un environnement de travail passionnant et dynamique, avec une dimension internationale
  • La possibilité de prendre des responsabilités et de développer votre potentiel
  • Une atmosphère de travail positive dans un cadre collaboratif et une culture d'entreprise pronant le respect et la reconnaissance
  • Des avantages sociaux attractifs, ainsi qu'une semaine de travail de 40 heures et 5 semaines de vacances par année
  • Un forfait annuel pour vos analyses personnelles et tarifs spéciaux pour les actes de radiologie effectués au sein du Groupe Unilabs

Contact

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Coordonnées

M. Antonio Gambin, 

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