<p>En tant que QA System Specialist vous serez responsable des activités opérationnelles quotidiennes liées aux processus de revues périodiques, d'implémentation des standards et de gestion documentaire et d'archivage, tout en garantissant la conformité du site aux standards GMP</p><p>Votre role:</p><ul><li>Gestion des revues périodiques : Vous assurez la gestion complète du cycle des revues périodiques en définissant le planning annuel selon les exigences GMP. Vous rédigez et actualisez les procédures, les modules de formation associés, et coordonnez la formation des employés du site. Responsable de la performance du système, vous pilotez l'amélioration continue via des projets, suivez les KPI et représentez le système lors des inspections HA et externes.</li></ul><ul><li>Gestion de l'implémentation des standards: Vous assurez le suivi des mises à jour des standards, guidelines et procédures globales. Vous coordonnez les activités de mise en conformité (CAPA, CCP) en veillant au respect des délais et suivez les indicateurs à remonter au Tier One.</li></ul><ul><li>Gestion du système documentaire et archivage: Vous gérez le traitement des documents et des archives . Vous participez également aux projets d'amélioration liés au système documentaire.</li></ul>

<p>Wir suchen per sofort oder nach Vereinbarung Kältesystem-Monteur / Mechatroniker Kältetechnik / Servicetechniker (w/m/d)</p><p> </p><p> </p><ul><li>Zusammenbau von kundenspezifischen Klimaanlagen nach technischen Vorgaben</li><li>Biegen und Löten der Rohrleitungen des Kältekreises</li><li>Mechanische Montage der kältetechnischen Komponenten in der Anlage</li><li>Vakuumieren und Befüllen des Kältekreises inkl. Kleben und Abdichten</li><li>Allgemeine mechanische Anpassungsarbeiten inkl. Schweissen</li><li>Mithilfe bei der Auslegung und Gestaltung von kundenspezifischen Klimaanlagen</li><li>Durchführen von Dichtheits- und Funktionsprüfungen inkl. Druck- und Temperaturmessungen</li><li>Mithilfe bei Leistungstests in der hauseigenen Klimakammer</li><li>Montage-, Service- und Inbetriebnahme von Klimaanlagen bei unseren Kunden</li><li>Selbstständige Diagnose und Behebung von Störungen an kältetechnischen Anlagen sowie Durchführung von Wartungs-, Service- und Umbauarbeiten</li><li>Einhaltung der Qualitäts-, Umwelt- und Sicherheits</li></ul><br />

<p>Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. We have more than 260 operating companies in more than 60 countries employing approximately 134,000 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA. <br /></p><p>DePuy Synthes Companies of Johnson & Johnson is the largest, most comprehensive orthopedic and neurological business in the world. DePuy Synthes offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, power tools and biomaterials. Our broad array of inspired, innovative and high-quality offerings, help advance the health and wellbeing of people around the world.<br /></p><p>The Systems Testing Technician contributes to the design characterization, verification and risk assessment of medical device implants and surgical instrumentation (power tools, digital robotics, etc.) as part of new product development and life cycle management projects. The person will execute test protocols to verify the safety and efficacy of the medical devices under assessment. This is a hands-on role which touches on various engineering disciplines required for formal testing of complex medical device systems, including mechanical, electrical, optical, firmware and software. </p>Position Responsibilities<br /><br /><ul><li>Work closely with system engineering team to execute on test protocols for medical devices, report data, and generate test reports</li><li>Document laboratory activities in established laboratory management systems</li><li>Communicate test findings, technical challenges, and proposed resolutions to teams and senior engineers.</li><li>Support various laboratory related activities (inventory and equipment management, general housekeeping)</li><li>Collaborate with other engineers, technicians or other support personnel to assist in optimizing test methods and evaluate improvements to existing processes (quality and efficiency). </li><li>Can be assigned to additional non-project related activities as required.</li></ul><br /><br />