Stage - Assistant.e qualité Dispositifs médicaux H/F at Withings

Issy-les-Moulineaux, Île-de-France, France

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Not SpecifiedCompensation

InternshipExperience Level

InternshipJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Motivé.e pour participer à la culture qualité d’une entreprise et aimez sensibiliser sur ce sujet
Bon sens de la communication et bon relationnel pour travailler en équipe
Pas peur de découvrir de nouveaux domaines (logiciels, intelligence artificielle, mécanique, électronique, chimie, …)
Préparez un diplôme en école de pharmacie, d’ingénieur ou un équivalent universitaire dans le domaine de l’Assurance Qualité/Affaires Réglementaires
Maîtrisez le pack Google/Microsoft Office
À l’aise en anglais à l’écrit comme à l’oral (rédaction de documents en anglais, entreprise à dimension internationale FR/HK/US)
Aimez apprendre, souhaitez acquérir de l’autonomie et participer aux prises de décision
Bonne capacité d’organisation pour gérer différents projets en parallèle et bon sens de l'analyse
Idéalement déjà eu un premier contact avec l’ISO 13485

Responsibilities

Contribuer au maintien et à l'amélioration des systèmes de Management de la Qualité (QMS - ISO 13485 et 14971, ISMS - ISO 27001, PIMS - ISO 27701) et de la documentation Qualité (rédaction, mises à jour, revues)
Comprendre et analyser les non-conformités, et proposer les actions pertinentes pour la résolution des problématiques (NC/CAPA)
Participer aux audits internes et externes
Mettre en place les procédures et documents relatifs aux normes ISO 42001 et ISO 62304
Assurer un support dans le maintien et la mise à jour des Systèmes de Managements de la Qualité (ISO 13485 et Règlementation USA - CFR 21 820)
Aider à la mise en place de l’IA Act et des normes relatives aux SaMD (Logiciel de Dispositifs Médicaux)

Skills

Key technologies and capabilities for this role

ISO 13485ISO 14971ISO 27001ISO 27701ISO 42001ISO 62304CFR 21 820CAPANon-conformitiesAuditsQMSSaMDAI Act

Questions & Answers

Common questions about this position

Is this position remote or on-site?

This is an on-site position.

What educational background is required for this internship?

Candidates should be preparing a degree from a pharmacy school, engineering school, or equivalent university in Quality Assurance/Regulatory Affairs.

What language skills are needed for this role?

Proficiency in English is required for both written and oral communication, as well as mastery of Google/Microsoft Office pack.

What is the team structure for the Quality department?

The Quality team is part of the Quality & Regulatory Affairs department, which has 7-8 people, and the intern will report to the QMS Manager.

What makes a strong candidate for this Quality Assistant internship?

Strong candidates are motivated to contribute to quality culture, have good communication and teamwork skills, are open to learning new domains, organized, analytical, and ideally have prior exposure to ISO 13485.

Withings

Designs and manufactures smart health devices

About Withings

Withings focuses on digital health technology by creating smart health devices like the ScanWatch, which monitor health metrics such as steps, sleep patterns, heart rate, and oxygen saturation. These devices cater to health-conscious individuals, athletes, and content creators who want to track and enhance their health and fitness. Customers can buy products directly from the Withings website, with flexible payment options including pay-later plans and interest-free installments, along with a 30-day return policy for added convenience. The accompanying mobile app syncs with the devices to help users track long-term health trends, fostering engagement and loyalty. Withings distinguishes itself through its award-winning customer service and a global community of over 1 million users who support each other in their health journeys. The company's goal is to empower individuals to take control of their health through accessible technology and community support.

Issy-les-Moulineaux, FranceHeadquarters

2008Year Founded

$89.5MTotal Funding

SERIES_BCompany Stage

Consumer Software, Healthcare, Consumer GoodsIndustries

201-500Employees

Risks

Increased competition from AI-powered health devices could challenge Withings' market position.

Complexity and installation issues of Omnia mirror may deter potential buyers.

Regulatory scrutiny on new health solutions like BPM Vision may delay market entry.

Differentiation

Withings offers a comprehensive range of smart health devices, including the ScanWatch.

The Omnia smart mirror provides a 360-degree view of health, enhancing user engagement.

Withings' direct-to-consumer model with flexible payment options sets it apart in the market.

Upsides

AI integration in devices like Omnia enhances personalized health insights and user satisfaction.

Expansion into cardiovascular health with BPM Vision and Cardio Check-Up attracts health-conscious consumers.

Growing interest in at-home health monitoring boosts demand for Withings' smart devices.

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