Quality Manager for Medical Devices (m/f/d)
What can you expect?
- You take care of the quality management system (QMS) and ensure compliance with all relevant laws, guidelines, and standards
- You implement and maintain QM standards, processes, and new regulatory requirements, particularly in accordance with ISO 13485 and IEC 62304
- You review and create regulatory process instructions (SOPs) and communicate with authorities
- You support the preparation of documents for the market authorisation of our Class I software medical devices, including compliance with standards
- You coordinate corrective and preventive actions (CAPA) and are responsible for risk management and change control
What do we offer?
- You will be part of a team that creates innovative solutions for oncological patients in the German healthcare system
- We offer flat hierarchies that allow a high degree of independence and freedom to develop your creativity and contribute your own ideas
- We are a dynamic and diverse team and value positive, direct and open interaction with each other
- We offer flexible working hours
- We are an Equal Opportunity Employer
Company Doctor
Paid Continuing Education
Parental Leave
Employee Discounts
Company Pension Scheme
Bonus System
Travel allowance
What should you bring along?
- You have a degree in quality management, engineering, medical technology, or a comparable qualification
- You possess sound knowledge of ISO 13485, IEC 62304 standards, and regulatory requirements for medical devices
- You have experience in risk management, CAPA processes, and quality audits
- You demonstrate strong communication skills and experience in liaising with authorities and implementing regulatory requirements
- You are able to train employees in quality topics and continuously improve the QM system
- You are fluent in written and spoken German and English, and it is nice to have experience with breast cancer
2 to 5 years of work experience required
Languages
Skill set
About Sidekick Health Germany GmbH
Sidekick Health ist ein weltweiter Vorreiter im Bereich der digitalen Gesundheit und Therapeutika und engagiert sich dafür, die patientenzentrierte Versorgung durch innovative Lösungen zu transformieren. Das Unternehmen wurde von zwei Ärzten gegründet und bietet eine vielfältige Palette digitaler Gesundheitsprogramme an, die von der Onkologie, über Herz-Kreislauf-Erkrankungen, Stoffwechselstörungen, bis zu entzündlichen Erkrankungen diverse Therapiegebiete abdecken. 2023 hat Sidekick Health die aidhere GmbH (jetzt Sidekick Health Germany GmbH) als dritten Unternehmensbereich - neben der Kooperation mit weltbekannten Pharmaunternehmen und der größten Krankenversicherung in den USA - für verschreibungsfähige digitale Therapeutika übernommen. Sidekick Health Germany ist Marktführer im Bereich der digitalen Gesundheitsanwendungen (DiGA) und hat mit dem ersten Produkt zanadio, einer digitalen, multimodalen Adipositastherapie, bereits mehr als 40.000 Menschen bei der Gewichtsreduktion unterstützen können. Sidekick hat sein Headquarter in Reykjavik und Hamburg und beschäftigt weltweit über 250 Mitarbeiter:innen.
By loading the map, cookies are set as specified in our data privacy. Learn more.
Frequently asked questions
Who or what is Campusjäger by Workwise?
Campusjäger is part of Workwise - a job platform that supports you throughout your entire career. We take care of recruiting for various companies and accompany you through the entire application process. Via Campusjäger by Workwise you can find jobs for students and graduates. You can manage your applications in your Workwise profile. Learn more about the connection between Workwise and Campusjäger.
Is the job I see still available?
Which documents do I need for my application?
That depends entirely on the job you are applying for. In many cases it is sufficient to upload your PDF resume or fill out your Workwise profile.
Where can I upload my records or documents?
You can upload your application documents in your Workwise profile. These can only be viewed by companies you are applying to.
Where can I find more information about the company?
You can find more information in the company profile of Sidekick Health Germany GmbH.
Can I process my application afterwards?
Yes, this is possible. In your application overview you can view your information and make changes. If you have already been invited to an interview, editing is no longer possible. However, you can still add general information and upload additional documents in your profile.
How do I get news about my application?
In your application overview at Workwise you have an overview of the application progress at any time. Additionally, we send you emails about the most important status changes.
Can I send several applications at once?
The number of your applications is not limited. An overview of your applications can be found at Workwise.
Can other companies see where else I have applied?
Can I also contact the company's contact person directly?
Personal contact is possible via chat as soon as you have been invited for an interview. Before that, you will receive all important status changes by e-mail. If you have any questions, you can contact your personal Candidate Manager:in from Workwise.
I don't think I meet all the requirements. Can I still apply?
What do I have to consider if I am not from Germany?
Please make sure to provide all necessary documents within your Workwise profile. It should include an EU work-permit (if you have no EU citizenship) and a CV at least. Depending on the position you are applying to, you could also be asked for a certificate of enrollment, a transcript of records or a language certificate. We would also recommend to inform yourself thoroughly in advance about visa regulations. Therefore you can use the official visa navigator from the Federal Foreign Office.
What do I have to consider if German is not my mother tongue?
Please take into account the job’s language requirements and make sure the requirements match your skills. In the job search you can use the language filter to find jobs without German language requirements. It is also helpful to provide language certificates. This section in our help center may support you during the application process.
Our job offer Quality Manager for Medical Devices (m/f/d) sounds promising? We're looking forward to your application.
