Aktuelle Jobs im Zusammenhang mit Technical Documentation Assessor of IVD Medical Devices - Munich - TÜV SÜD
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Medical Device Technical Specialist
vor 1 Woche
Munich, Bayern, Deutschland FSQ Functional Safety & Quality Experts GmbH Vollzeit{"h2": "About FSQ Experts", "p": "At FSQ Functional Safety & Quality Experts GmbH, we combine technical expertise with systematic approaches to achieve quality and functional safety for high-end products on time and within budget.", "h2": "Job Description", "ul": [{"li": "We are seeking a Technical Senior Consultant to support the development of innovative...
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Medical Device Technical Specialist
vor 1 Woche
Munich, Bayern, Deutschland FSQ Functional Safety & Quality Experts GmbH Vollzeit{"h2": "About FSQ Experts", "p": "At FSQ Functional Safety & Quality Experts GmbH, we combine technical expertise with systematic approaches to achieve quality and functional safety for high-end products on time and within budget.", "h2": "Job Description", "ul": [{"li": "We are seeking a Technical Senior Consultant to support the development of innovative...
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Senior Technical Consultant
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Senior Technical Consultant
Vor 3 Tagen
Munich, Bayern, Deutschland FSQ Functional Safety & Quality Experts GmbH VollzeitAbout FSQ Functional Safety & Quality Experts GmbHWe are a leading provider of innovative solutions for medical technology companies, helping them overcome know-how and resource bottlenecks in quality management, regulatory affairs, and system engineering.Job DescriptionWe are seeking a highly skilled Technical Senior Consultant to join our team of experts....
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Munich, Bayern, Deutschland FSQ Functional Safety & Quality Experts GmbH VollzeitAbout FSQ Functional Safety & Quality Experts GmbHWe are a leading provider of functional safety and quality expertise for medical device companies. Our team of experts helps clients overcome complex challenges and achieve compliance with regulatory requirements.Job SummaryWe are seeking a highly skilled Technical Senior Consultant to join our team. As a...
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Working Student Technical Documentation
vor 3 Monaten
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Electro-Mechanical Assembly Technician
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Electro-Mechanical Assembly Technician
vor 3 Wochen
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Working Student Technical Documentation
vor 3 Monaten
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Specialist Labeling
vor 4 Monaten
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Service Technician for Medical Devices
vor 4 Wochen
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Technical Documentation Lead
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Technical Documentation Lead
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Expert Technical Advisor for Medical Innovations
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Expert Technical Advisor for Medical Innovations
vor 2 Wochen
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Technical Service Support
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Technical Documentation Specialist
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Munich, Bayern, Deutschland 2W Technische Informations GmbH & Co. KG VollzeitAbout the RoleWe are seeking a highly skilled Mechatronics Project Manager to join our team at 2W Technische Informations GmbH & Co. KG. As a key member of our team, you will be responsible for managing projects related to technical documentation and communication for the Nutzfahrzeuge industry.Key ResponsibilitiesProject Management: Manage projects from...
Technical Documentation Assessor of IVD Medical Devices
vor 5 Monaten
Aufgaben
Assessing technical documentation, product dossiers and test results of production batches of in-vitro diagnostic products, most high-risk products as part of product conformity assessments according to the requirements of the IVDR
Preparing reports included deficiency reports in case of non-conformities according to the requirements of the In Vitro Diagnostic Medical Devices Regulation 2017/746
Delivering high-quality, reliable, and predictable services within defined timeframes
Serving as an internal point of contact for TDA matters as part of the interfaces with other departments, offering support of and close exchange with colleagues
Independent supervision of certification projects for our international customers as a project manager
Readiness for intensive familiarisation with the ISO 13485, ISO 9001, MDR and MDSAP standards
Optionally providing support during QMS audits of medical devices manufacturers according to ISO 13485
Possibility of attending medical conferences
Qualifikationen
University degree in a scientific studies, e.g. chemistry, biotechnology, biochemistry, bioengineering or comparable field of study (PhD is a plus)
At least four years of professional experience in the manufacturing environment of the health care sector, e.g. with a manufacturer of medical devices
At least two years of well-founded hands-on practical experience at design and development, quality management, manufacture, testing or regulatory affairs department is a plus
Experience in creating or evaluating of technical documentation including high risk medical devices with the currently applicable product standards and regulatory requirements according to IVDR
Sound knowledge of immunology, molecular biology and related techniques
Fluency in written and spoken English
Proven qualification as an auditor or quality manger is a plus
Excellent organisational and professional communication skills
Ability to work in a team, pronounced customer orientation and good self-organization
Curiosity and willingness to learn
Experience working with MS Office applications and programs
