Responsable Qualité – Dispositifs Médicaux (Endoscopie)

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      "postalCode": "78320",
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    "description": "<p><br></p>\n<p>📍 <span style=\"font-weight: bold\">CDI – Temps plein – Basé au Mesnil saint-Denis– Démarrage début 2026<br><br></span></p>\n<p>Europe Endoscope, filiale du groupe AMW Health, recherche son/sa <span style=\"font-weight: bold\">Responsable Qualité</span> afin d’accompagner la montée en puissance de son atelier spécialisé en endoscopie souple.</p>\n<p>Au carrefour du biomédical, de la mécanique de précision et des exigences réglementaires, vous serez le garant opérationnel de la conformité, de la performance et de l’amélioration continue de notre système qualité.<br><br></p>\n<p><span style=\"font-size: 18pt\">🎯 <span style=\"font-weight: bold\">Vos responsabilités</span></span></p>\n<ul>\n<li>Piloter le <span style=\"font-weight: bold\">Système de Management de la Qualité</span> selon les normes applicables (ISO 13485, traçabilité, procédures internes) en tant que Répresentant de la Direction.</li>\n<li>Structurer, mettre à jour et faire évoluer l’ensemble des processus qualité et production.</li>\n<li>Superviser et valider les Inspections qualité des endoscopes entrants et sortants.</li>\n<li>Suivre les indicateurs qualité, animer les revues, mettre en œuvre les actions correctives et préventives.</li>\n<li>Former et accompagner les équipes techniques aux bonnes pratiques qualité.</li>\n<li>Assurer la conformité documentaire (enregistrements, rapports, audits internes).</li>\n<li>Participer activement à la stratégie qualité et aux projets transverses de croissance du site.</li>\n</ul>\n<p><span style=\"font-size: 18pt\">👤 <span style=\"font-weight: bold\">Profil recherché</span></span></p>\n<ul>\n<li>Bac+3 à Bac+5 en <span style=\"font-weight: bold\">Qualité</span>, <span style=\"font-weight: bold\">Biomédical</span>, <span style=\"font-weight: bold\">Mécanique/Électrotechnique</span> ou domaine connexe.</li>\n<li>Expérience confirmée (minimum 3–5 ans) en qualité dans le secteur <span style=\"font-weight: bold\">biomédical</span>, <span style=\"font-weight: bold\">dispositifs médicaux</span>, <span style=\"font-weight: bold\">atelier technique</span> ou environnement réglementé.</li>\n<li>Connaissance des normes <span style=\"font-weight: bold\">ISO 13485</span> nécessaires.</li>\n<li>Maîtrise des outils informatiques et des systèmes de gestion (Microsoft Office, obligatoire et Salesforce idéale).</li>\n<li>Rigueur, leadership, sens du détail, esprit analytique et forte capacité d’adaptation.</li>\n<li>Aisance relationnelle et capacité à insuffler une culture qualité structurée et collaborative.</li>\n</ul>\n<p><span style=\"font-size: 18pt\">🌱 <span style=\"font-weight: bold\">Ce que nous offrons</span></span></p>\n<ul>\n<li>Contrat CDI au sein d’un atelier reconnu pour son savoir-faire technique.<br></li>\n<li>5 semaines de congé payé.</li>\n<li>Tickets restaurant.<br></li>\n<li>Jour d’anniversaire offert.</li>\n<li>Environnement dynamique, en pleine croissance, avec du matériel médical de pointe.</li>\n<li>Une culture d’entreprise animée par des valeurs fortes : <span style=\"font-weight: bold\">Résultats – Croissance – Conscience – Transparence – Détermination</span>.</li>\n</ul>\n<p><br></p>\n<p><br></p>\n<p><span style=\"font-weight: bold\">📍Permanent Contract (CDI) – Full-time – Based in Le Mesnil-Saint-Denis – Starting early 2026</span></p>\n<p><span style=\"font-weight: bold\">Europe Endoscope, </span>a member of the <span style=\"font-weight: bold\">AMW Health Group</span> is seeking a <span style=\"font-weight: bold\">Quality Manager</span> to support the scale-up of its workshop specialized in flexible endoscopy.</p>\n<p>At the crossroads of biomedical engineering, precision mechanics, and regulatory requirements, you will be the operational guarantor of compliance, performance, and continuous improvement of our Quality Management System.</p>\n<p> </p>\n<p><span style=\"font-size: 18pt; font-weight: bold\">🎯 Your Responsibilities</span></p>\n<ul>\n<li>Lead the Quality Management System in accordance with applicable standards (ISO 13485, traceability, internal procedures).</li>\n<li>Structure, update, and continuously improve all quality and production processes.</li>\n<li>Supervise and validate quality inspections of incoming and outgoing endoscopes.</li>\n<li>Monitor quality indicators, lead reviews, and implement corrective and preventive actions.</li>\n<li>Train and support technical teams in quality best practices.</li>\n<li>Ensure documentary compliance (records, reports, internal audits).</li>\n<li>Actively contribute to the quality strategy and cross-functional growth projects of the site.</li>\n</ul>\n<p><span style=\"font-size: 18pt; font-weight: bold\">👤 Profile Sought</span></p>\n<ul>\n<li>Bachelor’s to Master’s degree in Quality, Biomedical Engineering, Mechanical/Electrotechnical Engineering, or a related field.</li>\n<li>Proven experience (minimum 3–5 years) in quality within the biomedical sector, medical devices, technical workshops, or regulated environments.</li>\n<li>Solid knowledge of ISO 13485 standards.</li>\n<li>Proficiency in IT tools and management systems (Microsoft Office required; Salesforce is a plus).</li>\n<li>Strong rigor, leadership, attention to detail, analytical mindset, and high adaptability.</li>\n<li>Excellent interpersonal skills with the ability to foster a structured and collaborative quality culture.</li>\n</ul>\n<p><span style=\"font-size: 18pt; font-weight: bold\">🌱 What We Offer</span></p>\n<ul>\n<li>Permanent contract within a workshop recognized for its technical expertise.</li>\n<li>5 weeks of paid leave.</li>\n<li>Meal vouchers.</li>\n<li>Birthday day off.</li>\n<li>A dynamic, fast-growing environment working with state-of-the-art medical equipment.</li>\n<li>A company culture driven by strong values: <span style=\"font-weight: bold\">Results – Growth – Awareness – Transparency – Determination</span>.</li>\n</ul>",
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