Aktuelle Jobs im Zusammenhang mit Quality Manager Medical Devices - Bad Homburg - FRESENIUS_KABI
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Medical Device Compliance Expert
vor 2 Wochen
Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Medical Care VollzeitAbout the RoleWe are seeking a highly skilled Medical Device Compliance Expert to join our team at Fresenius Medical Care. As a key member of our Regulatory Affairs department, you will be responsible for ensuring the compliance of our medical devices with relevant regulations.Key ResponsibilitiesDevelop and maintain technical documentation and regulatory...
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Medical Device/ Drug Compliance
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Senior Engineer for Medical Device Development
vor 2 Wochen
Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Medical Care VollzeitAbout the RoleWe are seeking a highly skilled Senior Systems Engineer to join our team as a Design Lead for Peritoneal Dialysis Systems. As a key member of our engineering team, you will be responsible for the development of systems, sub-systems, and components, as well as the execution of concept and feasibility analyses with a focus on functional...
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Senior Engineer for Medical Device Development
vor 2 Wochen
Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Medical Care VollzeitAbout the RoleWe are seeking a highly skilled Senior Systems Engineer to join our team as a Design Lead for Peritoneal Dialysis Systems. As a key member of our engineering team, you will be responsible for the development of systems, sub-systems, and components, as well as the execution of concept and feasibility analyses with a focus on functional...
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Global Manufacturing Engineering Project Manager
vor 1 Monat
Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Medical Care VollzeitPosition Overview: Engineering Project Manager We are seeking a skilled Project Manager to oversee initiatives within the realm of global manufacturing engineering and service technologies. This role is pivotal in enhancing the production transition of medical devices, ensuring that our processes align with the highest standards of quality and...
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Quality Assurance Specialist and QMS Manager
vor 1 Monat
Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Medical Care VollzeitObjective of the Role: The Quality Assurance Specialist and QMS Manager plays a pivotal role in assisting senior Quality Specialists to ensure the successful execution and upkeep of the Quality Management System (QMS) within the IT division. This position emphasizes operational support across a range of quality assurance functions to maintain standards...
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Global Manufacturing Engineering Project Manager
vor 1 Monat
Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Medical Care VollzeitPosition Overview: Engineering Project Manager We are seeking a skilled Project Manager to oversee initiatives within the realm of global manufacturing engineering and service technologies at Fresenius Medical Care. This role is pivotal in driving the transition of medical device production, ensuring that our projects align with industry standards and...
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Global Manufacturing Engineering Project Manager
vor 1 Monat
Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Medical Care VollzeitPosition OverviewWe are seeking a dedicated Project Manager to oversee initiatives within the realm of global manufacturing engineering and service technologies at Fresenius Medical Care. This role is pivotal in ensuring the effective planning, execution, and management of projects aimed at enhancing the production of medical devices.Key ResponsibilitiesLead...
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Medical Equipment Maintenance Specialist
vor 1 Monat
Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Medical Care VollzeitOBJECTIVE: This entry-level role is designed to cultivate essential Knowledge, Skills, and Abilities (KSA) within a guided framework, aiming for the development of independent operational capabilities following comprehensive training. Under close supervision, the technician will engage in routine maintenance and repair of medical apparatus, ensuring...
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Medical Equipment Maintenance Specialist
vor 1 Monat
Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Medical Care VollzeitOBJECTIVE: This entry-level role is designed to cultivate essential Knowledge, Skills, and Abilities (KSA) within a guided framework, aiming for the development of independent operational capabilities following comprehensive training. Under close supervision, the technician will engage in routine maintenance and repair of medical apparatus, ensuring...
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Software Quality Engineer II
vor 1 Monat
Bad Homburg, Deutschland Fresenius Medical Care VollzeitGoal of Function: This role will support the validation of computerized systems within the Quality Management and Regulatory Systems department, ensuring compliance with regulatory requirements and industry standards. This position requires knowledge and experience with TrackWise, IQVIA SmartSolve, and Quality Management Systems (QMS). Tasks &...
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Global Manufacturing Engineering Project Manager
vor 1 Monat
Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Medical Care VollzeitPosition OverviewAs a Project Manager at Fresenius Medical Care, you will take on a pivotal role in steering projects that are essential to the global transition of medical device production. Your responsibilities will encompass the planning, execution, and supervision of initiatives aimed at enhancing production processes and technologies for future medical...
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Quality Assurance Supervisor
vor 3 Wochen
Bad Homburg, Deutschland Fresenius Medical Care VollzeitTasks performed regularly which form the essential characteristics of the position. Leadership Provide structured reporting, process improvement proposals and recommendations in the respective process area. Identifies and drives changes in a future-oriented, solution-oriented and proactive manner Ensures a strong and motivated team, ensures a...
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Supply Chain Quality Director
vor 3 Wochen
Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Medical Care VollzeitJob Summary:Fresenius Medical Care is seeking a highly experienced Supply Chain Quality Director to lead our quality management efforts in the supply chain. As a key member of our team, you will be responsible for ensuring compliance with national and international storage and distribution requirements, qualifying suppliers and service providers, and...
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Medical Equipment Maintenance Specialist
vor 1 Monat
Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Medical Care VollzeitOverview of the Position: As a Biomedical Equipment Technician at Fresenius Medical Care, your primary responsibility will be to ensure the proper functioning and upkeep of medical and water treatment devices utilized in our kidney care facilities. You will also play a crucial role in training and guiding team members on the operational maintenance of...
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Learning & Development Manager (m/f/d) MedTech
vor 2 Monaten
Bad Homburg, Deutschland FRESENIUS_KABI VollzeitThe Learning and Development Manager is responsible for the creation, implementation, and management of training and development programs within the MedTech division across Europe. This ensures that all employees have the necessary skills and knowledge to meet the organization's objectives and comply with regulatory standards. Your assignments Manage...
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International (Senior) Product Manager (m/w/d)
vor 3 Monaten
Bad Homburg, Deutschland Fresenius Medical Care, Global Research & Development VollzeitWe are looking for a dynamic and experienced International ( Senior) Product Manager (m/f/d) to lead a critical care product portfolio on a global scale. As the expert for Fresenius Medical Care's AKI therapy systems , you will play a key role in driving strategic initiatives, product development, and market penetration strategies. The focus here is...
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Quality Assurance Team Leader
vor 1 Monat
Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Medical Care VollzeitPosition OverviewThe Quality Assurance Supervisor is responsible for overseeing the essential functions of the QA team, ensuring high standards of quality and compliance throughout the organization.Leadership ResponsibilitiesDeliver structured reports and propose process enhancements within the designated area.Proactively identify and implement...
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Medical Equipment Maintenance Specialist
vor 1 Monat
Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Medical Care VollzeitOBJECTIVE: Under supervision, the incumbent is accountable for ensuring the operational efficiency, upkeep, and repair of all medical apparatus, water systems, and mechanical/electrical infrastructures, thereby safeguarding the well-being of both patients and staff utilizing the equipment. Responsibilities also include inventory management and...
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Quality Assurance Team Leader
vor 1 Monat
Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Medical Care VollzeitPosition OverviewThe Quality Assurance Supervisor is responsible for overseeing essential functions within the quality assurance domain, ensuring optimal performance and compliance.Leadership ResponsibilitiesDeliver structured reports and propose process enhancements within the designated area.Proactively identify and implement future-oriented...
Quality Manager Medical Devices
vor 4 Monaten
As Quality Manager you will act as Deputy for the Head of Quality Compounding Devices (Quality Management Representative) and report to him. In this role you will ensure compliance in Development Projects incl. Risk Management.
Further responsibilities:
Quality Approver for Events, Complaints, CAPAs and Change Controls Execution of Incoming Goods Inspection and preparation of batch & device release documentation Preparation, monitoring and support of audits and inspections (internal and external) Collection and Preparation of Quality Key Performance Indicators Review, Update and (if necessary) Approval of SOPs and WIs incl. Training Support or execute investigations / Root Cause Analysis and related definition of actions Support Risk Management activities, Qualifications & Validations and Supplier Quality Management
Your profile
Graduate degree in engineering in the field of electrical engineering, mechanical engineering, medical technology or similar Several years of experience in Medical Device Industry (R&D, Manufacturing, Quality Control), Supplier Quality Management and Quality Assurance Very good knowledge of ISO 13485, ISO 9001 and ISO 14971 Founded knowledge of the GMP regulations and the regulation 21 CFR Part 820 Experience with TrackWise (Sparta System) and Auditing (certification as Lead Auditor is a plus) Fluent English and German, both written and spoken Structured, pragmatic and self-reliant way of working