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About the Role
We are looking for support for the Quality Management team at our subsidiary tPM (tomedo Praxissoftware Medizin GmbH). Our QM system already has considerable substance: TeleScan, a certified medical product, is already on the market, our first AI-supported medical product is close to submission to the Notified Body, and in 2027, our first recertification according to EN ISO 13485 awaits us.
Responsibilities
- Continuously develop our established quality management system and define, coordinate, and track measures for improvement and maintenance.
- Develop necessary documentation stringently with our specialist departments, ensuring quality-relevant documents, proof documentation, and technical documentation are always to the point and practical.
- Ensure that MDR, IEC 62304, IEC 62366-1, ISO 14971, and the AI Act for high-risk AI systems work together seamlessly as our product portfolio expands with AI-supported medical products (Class IIa/IIb).
- Contribute to the integration of AI into our QM process landscape and actively drive the use of AI for QM tasks.
- Professionally support certifications and audits, including with our Notified Body, maintaining an overview and implementing necessary changes structurally with all stakeholders.
- Inform management about quality-related data and present ideas for improving products and processes persuasively.
Requirements
- Successfully completed a technical or scientific degree.
- Possess knowledge of quality management or a strong desire to start in this field.
- Have professional experience in the development or manufacturing of medical devices, ideally with a software component or AI.
- Prioritize quality in your work.
- Have experience with QM or be eager to gain it.
- Keep MDR, ISO 14971, and ISO 13485 in mind.
- Familiarity with or willingness to quickly learn IEC 62304, IEC 62366-1, or the AI Act for high-risk AI systems.
- Approach tasks in a goal-oriented and human manner.
- Excel at documentation and simplifying complex issues into understandable language.
- Communicate at an excellent German level (at least C1) for internal team communication and interaction with specialist departments and the Notified Body.
Skills
- Quality Management
- Medical Device Development
- Software Development
- AI
- MDR
- IEC 62304
- IEC 62366-1
- ISO 14971
- ISO 13485
- AI Act
- Documentation
- Communication (German C1)
Location
- Germany (Remote)
Work Type
- Home Office
- Part-time (minimum 30 hours/week)
Experience Level
- Professional experience in medical device development/manufacturing
Education Level
- Technical or scientific degree
Benefits
- Flexible working hours
- Home Office/Mobile Working
- Team Events
- Promotion of physical and mental health
- Company pension scheme
- Company health insurance
- Company bicycle leasing/Jobrad
- Hardware leasing
- Employee discounts
- Childcare cost subsidy/Kita subsidy
- Recreation allowance
- Meal allowance
- Travel expense allowance
- Work abroad
- Tax-free shopping card
- Fruit basket
About the Company
- We are an innovative, creative, and established family company based near Paradise in Jena.
- We collectively develop tomedo®, our rapidly growing Apple-based software for medical practices, which has achieved the highest customer satisfaction in independent surveys.
- We foster a flat hierarchy and communicative collaboration, allowing creativity and ideas to flourish in exciting projects.
- We offer Home Office and flexible working hours to enable personalized daily routines.
- We provide opportunities for professional development and active contribution to the growth of zollsoft GmbH.
- We are an open and ambitious team of over 600 employees who truly live customer orientation and have fun.
- We maintain a startup atmosphere after more than 10 years.
- We understand ourselves as a closely knit team with a cooperative rather than competitive atmosphere.
- We organize events such as beach volleyball in summer, barbecues, cooking evenings, or paddling tours.