Quality Manager (f/m/x) at PINK! (20h)
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
- You have 20hours of time per week
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.
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