Chargé(e) Assurance Qualité- Dispositif Médical

CMS

Chargé(e) Assurance Qualité- Dispositif Médical

Description de l'emploi
ZOLL est une société du groupe Asahi Kasei, qui développe, fabrique et commercialise des dispositifs médicaux et des solutions logicielles, pour le diagnostic et le traitement de graves affections cardiopulmonaires et respiratoires.
En France, l’activité est principalement centrée sur le dispositif médical LifeVest, un défibrillateur portable destiné aux patients à risque d’arrêt cardiaque soudain. Inscrite sur la liste LPP, la LifeVest permet d’assurer un suivi rapproché de ces patients à domicile.
Dans un contexte de forte croissance et d’évolution constante de la réglementation, ZOLL France recrute un(e) chargé(e) en Assurance Qualité.
Rattaché(e) à la Responsable Assurance Qualité et Affaires Réglementaires, vous participerez activement à la mise en place d’un Système de Management de la Qualité conformément aux exigences de la norme ISO 13485. Vous interviendrez notamment sur la gestion des non-conformités et des actions correctives et préventives (CAPA).

Les principales missions :
- Participer à la mise en place d’un Système de Management de la Qualité (SMQ) conforme à la norme ISO 13485
- Participer à la rédaction, à la mise à jour et à la gestion documentaire (procédures, instructions, enregistrements, etc.)
- Gérer le processus des non-conformités (NC) et des CAPA et en assurer le suivi
- Mettre en place des audits et des contrôles pour identifier les écarts et renforcer le process NC/ CAPA
- Participer à l'analyse et à l'amélioration des processus de l'entreprise et à la mise en place et au suivi des indicateurs de performance
- Contribuer à la formation des collaborateurs aux exigences du SMQ et à leur sensibilisation à la culture qualité
- Travailler de manière transversale avec toutes les divisions ZOLL Medical France ainsi qu’avec les prestataires de ZOLL Medical France, les équipes EMEA et le Corporate aux US.




Pourquoi rejoindre ZOLL Medical France :
- Une opportunité unique de contribuer à la construction d'un Système de Management de la Qualité ISO 13485 au sein d'un leader international du dispositif médical.
- Une expérience en assurance qualité orientée sur les processus clés tels que la gestion des non-conformités et des CAPA
- Une immersion dans un système qualité exigeant, conforme à la norme ISO 13485 et aux réglementations applicables
- Une structure à taille humaine où règnent entraide et esprit d’équipe
- Un environnement de travail agréable

Les qualités et compétences requises pour rejoindre notre équipe sont :
- Rigueur, curiosité et pragmatisme
- Esprit d’équipe, d’analyse et de synthèse
- Maîtrise de l’anglais
- Connaissance de la norme ISO 13485
- La connaissance de la réglementation européenne (MDR 2017/745) est un plus

Formations requises :
Formation scientifique, médicale ou ingénieur (Bac +5), assortie d’une première expérience réussie en assurance qualité dans le domaine du dispositif médical, idéalement avec une exposition au traitement des non-conformités et des CAPA.

Informations pratiques :
- Contrat : CDD de 12 mois à temps plein
- Lieu : Le poste est basé en Ile de France dans les Yvelines (78) au Centre d’affaires de Voisins Le Bretonneux.
- Date de démarrage souhaitée : Décembre 2026.At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.

ZOLL Cardiac Management Solutions offers a unique portfolio of novel technologies designed to deliver better insights and better outcomes. On any given day, clinicians utilize these ZOLL products for tens of thousands of cardiac patients around the world:

• LifeVest, the world's first wearable defibrillator, has been trusted to protect more than 1M patients at risk of sudden cardiac death.
• HFMS (Heart Failure Management system) is a non-invasive, patch-based device that monitors pulmonary fluid levels and has been shown to reduce heart failure readmissions rates by 38 percent.
• TherOx Super Saturated Oxygen (SSO2) Therapy is the first FDA-approved therapy since the stent 20+ years ago to reduce infarct size in patients with the most severe heart attacks.

Heart disease is the leading cause of death for both men and women in the U.S. At ZOLL, your work will help to ensure cardiac patients get the life-saving therapy they need.

ZOLL has been Pittsburgh's Manufacturer of the Year, one of Western PA's Healthiest Employers, and even one of Pittsburgh's Coolest Offices. But it's our unique opportunity to impact people's lives that makes ZOLL the ideal place to build your career.

Job Summary

Performs a variety of complex tasks related to Quality Assurance including, but not limited to: performing trend analyses on quality data to provide early warning of potential problems and improvement opportunities. Develop, implement, and manage value improvement projects which incorporate a Lean/Six-Sigma approach. Perform analyses on quality information to proactively improve potential problems and capture improvement opportunities including non-product software

Essential Functions

• Performs internal quality audits and effectiveness reviews (FDA’s QSR, ISO 13485, MDD, CMDR) Conducts supplier evaluations and audits
• Responsible for the development and execution of Lean/six-Sigma and other cost improvement initiatives that can be related to product quality
• Responsible to understand the appropriate legal and regulatory requirements in the areas of medical device operations and to establish robust processes and controls to ensure compliance
• Responsible to build and improve key business relationships within the organization’s cross functional departments
• Ensure operations quality measurement systems are capable (Gauge R&R), process capability (Cpk) is high and process controls are in place to assure that products meet specifications
• Ensure that equipment is calibrated and maintained in accordance with requirements, and that these activities are properly documented
• Conducts various risk analysis activities for new and existing products including FMEAs and Fault Tree Analyses
• Prepare, submit and coordinate the process validation requirements for non-product software validations
• Participates in the FDA premarket approval process (PMA) for new and modified medical devices
• Participates in the nonconforming material/Material Review Board process Championing the implementation of Lean Manufacturing processes
• Participate in Kaizen events as a representative of the quality department

Required/Preferred Education and Experience

• Bachelor's Degree Requires a BS degree or equivalent experience in a technical or scientific discipline. required
• Experience in an FDA regulated Class III electrical medical device manufacturing environment preferred. preferred and
• Experienced in process development and validation for electro-mechanical assembly, test, and service. required and
• Formal Project management experience a plus preferred and
• Lean experience preferred and
• Experience with database queries and reporting in SQL or Microsoft Access preferred
• Six Sigma Green Belt Certification Preferred or
• Black Belt Preferred

Knowledge, Skills and Abilities

• Understands and has applied in practice the concepts of process capability, process control, and measurement system capability.

Physical Demands

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this Job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand; walk and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds.

Working Conditions

• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• The noise level in the work environment is usually quiet.

ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients' lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.