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Quality manager

Neuenburg
OK JOB SA
Qualitätsmanager
Inserat online seit: 10 Juni
Beschreibung

For one of our clients, we are looking for a: Quality Manager - Medtech - GER / ENGHigher technical education (ES/HES), supplemented by training in quality managementConfirmed experience in quality assurance in a Medtech production environmentExperience in team management and a strong interest in technical subjectsGood knowledge of ISO 13485, FDA 21 CFR Part 820, CAPA, audits, and change managementExperience in Regulatory Affairs = a plus or good knowledge of LeanConfident communication with internal departments, clients, and suppliersGood command of MS Office, CAQ/ERP experienceLanguages: French and German = fluent; English = good levelThe benefits:A key position with overall quality responsibility for two sitesA demanding Medtech environment oriented towards continuous improvementAn open culture, quick decisions, and an open-door philosophyIndividual development opportunities6 weeks of vacation, social benefits, team events, and loyalty bonusesOur client, a company active in the development and manufacturing of solutions for medical technologies, is looking for a Quality Manager for two sites in French-speaking Switzerland. You will play a key role in steering the quality system, managing the QA team, and continuous improvement.Ensure the Quality Management function for the QMS ISO 13485 harmonized across 2 sitesManage the QA team of both sites and guarantee overall responsibility for local quality activitiesMaintain and improve the QMS ISO 13485, FDA 21 CFR Part 820, and applicable standardsLead internal, client, and notified body audits, from preparation to follow-up of actionsBe the main point of contact for clients, authorities, notified bodies, and partners on quality subjectsSupervise key QA processes: CAPA, change management, and audit managementMonitor quality KPIs, report QMS ISO 13485 performance to management / Global QA, and drive continuous improvementManage QA resources, team leadership, and budgetSupport Regulatory Affairs activities jid95847cbaen jit0624aen jpiy26aen

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