Germany Job Openings
Vivira
Quality Manager (m/f/d)
Berlin
FULL TIME
November 4, 2024
The app on prescription for back pain.
About Vivira
Vivira Health Lab is a digital health company that develops simple and effective digital solutions for musculoskeletal disorders. Our mission is to improve the lives of our patients by giving them the tools they need to take control and achieve a better quality of life.
Our first product is an app-based therapeutic training for back pain that is patient-centered and personalized, enabling individuals to independently manage and reduce their pain regardless of time and place.
As one of the first digital health apps ever to be included in the general reimbursement list Di GA of the German Federal Institute for Drugs and Medical Devices (Bf Ar M), it can be prescribed by all doctors in Germany, with the costs covered by all statutory health insurers, and without being restricted by traditional therapeutic budgets.
We are a growing company with an international and diverse team headquartered in Berlin. We are dynamic, goal and quality oriented, and we love the entrepreneurial spirit. We are constantly exploring new possibilities and pushing the boundaries of what is possible to meet the individual needs of our patients and prescribing doctors. Our team members work on exciting projects that have a direct impact on the world around us.
Our company culture is based on our core values. These are: Truthful Positivity, Competitive Drive, Proactive Competence, Humility, and Caring Kindness. We offer a supportive and inclusive workplace that welcomes diversity and teamwork. We believe that our success as a company is directly related to the success of our employees.
Your tasks with us
- Manage changes for existing products
- Develop and document new products
- Create and update Technical Documentation (in accordance with MDR) for existing and new products
- Improve internal processes and infrastructure, e.g. through the use of tools
- Coordinate and implement new requirements for our products, e.g. TI, BSI, Di GA data protection criteria
- Improve the QM system with the help of internal audits, CAPAs, process management, data analyses, changes, etc.
- Create and maintain our documentation, e.g. processes and document templates
- Prepare and participate in external audits (e.g. 13485 / 27001)
What you should bring
- You have at least a Bachelor's degree in a relevant subject, e.g. engineering, business informatics, etc.
- You have at least 2-3 years of experience in quality management, ideally in digital health
- You are familiar with various requirements for manufacturers of digital medical devices (e.g. MDR, 13485, 27001)
- Ideally, you have worked as a QMB, developer / QA or in a similar role
- You enjoy liaising with other teams and taking responsibility for driving topics forward
- You are adept at communication and coordination within the entire company
- You are willing to learn, find practical solutions and implement them
- Excellent written and spoken English skills and good German skills; other European languages are an advantage
What to expect at Vivira
- A high degree of personal responsibility and independence
- The opportunity to be part of a meaningful company at the forefront of the digitalisation of healthcare
- A positive, dynamic and open company culture
- The opportunity to work from another EU country for up to 1 month a year
- The possibility of a company pension scheme
- 30 vacation days
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