Technical Documentation Assessor of Active Medical Devices

Tasks

• Assessing Technical Documentation as part of product conformity assessments of Active Medical Devices according to the requirements of the Medical Device Regulation 2017/745
• Preparing reports included deficiency reports in case of non-conformities according to the requirements of the Medical Device Regulation 2017/745
• 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

Qualifications

• APPLICATION PROCESS:
• To begin the application process please fill out the survey on the following link and we will get in touch with you: https://forms.office.com/r/YFnPfFHbtA
• University degree in technical or scientific studies, e.g. biomedical engineering, mechanical engineering, electronic engineering, electrical engineering, computer engineering or comparable field of study
• 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 and for medical devices class III with the currently applicable product standards and regulatory requirements according to MDR
• Technical product knowledge in the field of medical technology
• 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

Further Information/Weitere Informationen

• Benefits:
• Employment based on an employment contract full time / permanent
• Access to a package of employee benefits
• Opportunity for development and professional training
• Work in a group of specialists, in a company with an established position on the market
• Friendly atmosphere
• Necessary work tools
• Possibility to work remotely
• APPLICATION PROCESS:
• To begin the application process please fill out the survey on the following link and we will get in touch with you: