Junior QM-Manager / QA Specialist – Fokus GDP & MDR

Junior QM-Manager / QA Specialist (w/m/d) – Fokus GDP & MDR 塑造牙科行业的未来。 Abc Dental AG 和 Condor Dental Research Co. Ltd. 是瑞士牙科行业中成熟的合作伙伴。作为全球领先的医疗保健公司 Henry Schein 的子公司，我们将区域性的客户亲密度与国际实力相结合。我们共同为牙科诊所和医疗保健专业人员提供高质量的产品、创新的解决方案和卓越的服务。我们约 100 名敬业的员工受益于现代化的工作环境、短决策路径以及全球成功企业的职业发展机会。 为了加强我们的 QM 团队，我们在 Zürich 或 Vouvry 地区招聘以下职位： Junior QM-Manager / QA Specialist (w/m/d) – Fokus GDP & MDR 具有成为技术负责人员 (FvP) 副职的前景 工作量：50% – 60%（经协商） 重点：国内批发领域的运营 QA、GDP 合规性 & 医疗器械 (MDR) 发展：有针对性的入职培训和资质认定，以担任向当局申报的 FvP 副职 您的职责范围 QMS 支持：您将维护并优化我们现有的药品和医疗器械质量管理体系（根据 GDP、MDR、ISO 13485）。 合规性与日常运营：您将监督国内批发领域对 GDP 指南的遵守情况，并确保符合 QMS 标准的文件控制和归档。 质量流程：您将独立处理偏差、变更（Change Control）、投诉和 CAPA 措施。 审计准备：您将支持团队准备 Swissmedic 的检查以及内部自我检查。 FvP 发展路径：您将逐步接触根据 AMBV 规定的技术负责人员 (FvP) 的职责，以便在中期内合法承担副职角色。 您的要求 教育背景：药学、化学、生物学学位或类似的自然科学/技术资质。 工作经验：在质量保证 (QA) 或质量管理 (QM) 领域具有初步或多年的实践经验，理想情况下是在制药或医疗器械行业。 专业知识：具备瑞士医疗产品法（HMG, AMBV, GDP）以及国际标准（ISO 13485 / MDR）的基础知识或初步接触经验者优先。 语言能力：流利的德语以及良好的法语和英语能力（对于跨地点协作至关重要）。 工作方式：严谨、结构化的工作方式，并有深入研究监管议题的动力。 我们为您提供 发展：一个明确定义的职业发展计划，目标是承担当局指定的 FvP 副职。 灵活性：现代化的雇佣条件、灵活的工作时间和每周最多 2 天的居家办公。 企业文化：开放的公司文化、扁平化的层级结构和同事间的良好工作氛围。 团队活动：定期的集体活动和团队活动，一定会让您感到兴奋。 您感兴趣吗？ 那么我们期待您的申请！请将您的完整申请材料（包括您的薪资期望）发送给 Nadine Claus。如有关于职位的疑问，请直接联系 Dr. Benjamin Kraus。 Shaping the Future of the Dental Industry Together. Abc Dental AG and Condor Dental Research Co. Ltd. are among the established partners in the Swiss dental industry. As subsidiaries of Henry Schein, the world’s leading healthcare company, we combine regional customer focus with international strength. Together, we support dental practices and healthcare professionals with high-quality products, innovative solutions, and excellent service. Our approximately 100 dedicated employees benefit from a modern work environment, short decision-making processes, and the development opportunities offered by a globally successful company. To strengthen our QM team in the Zurich or Vouvry area, we are looking to fill the following position: Junior QM Manager / QA Specialist (f/m/d) – Focus on GDP & MDR With prospects to become the Deputy Responsible Person (RP / FvP) Workload: 50% – 60% (by agreement) Focus: Operational QA, GDP Compliance & Medical Devices (MDR) in domestic wholesale Development: Targeted onboarding and qualification to officially assume the legal role of Deputy RP Your Responsibilities QMS Support: You maintain and optimize our existing Quality Management System for pharmaceuticals and medical devices (according to GDP, MDR, and ISO 13485). Compliance & Daily Operations: You monitor compliance with GDP guidelines in domestic wholesale and ensure QMS-compliant document control and archiving. Quality Processes: You independently handle deviations, changes (Change Control), complaints, and CAPA measures. Audit Preparation: You support the team in preparing for inspections by Swissmedic or Notified Bodies, as well as conducting internal self-inspections. RP Development Path: You will be gradually introduced to the duties of the Responsible Person (FvP) under Swiss law (AMBV), with the mid-term goal of legally taking over the deputy function. Your Profile Education: Degree in Pharmacy, Chemistry, Biology, or a comparable scientific/technical qualification. Professional Experience: Initial or several years of practical experience in Quality Assurance (QA) or Quality Management (QM), ideally within the pharmaceutical or medical device industry. Technical Knowledge: Basic knowledge or first points of contact with Swiss therapeutic products law (HMG, AMBV, GDP) and international standards (ISO 13485 / EU-MDR) are an advantage. Language Skills: Professional fluency in German, along