Quality Manager (f/m/x) at PINK! (20h)

Festanstellung, Teilzeit · Hamburg

Your mission with us

As a Quality Manager (f/m/x) at PINK!, you will be responsible for the implementation, monitoring and continuous improvement of our quality management system, ensuring that our products meet the highest standards and fulfill all legal requirements.

What you can expect from us

Taking care of the PINK! quality management system (QMS) and ensuring compliance with all relevant laws, guidelines and standards.
Implementation and maintenance of QM standards, processes and new regulatory requirements, in particular in accordance with ISO 13485 and IEC 62304.
Reviewing and creating regulatory process instructions (SOPs) and communicating with authorities.
Support in the preparation of documents for the market authorisation of our Class I software medical devices, including compliance with standards.
Coordination of corrective and preventive actions (CAPA) as well as responsibility for risk management and change control.

Your profile

Degree in quality management, engineering, medical technology or comparable qualification.
Sound knowledge of ISO 13485, IEC 62304 standards and regulatory requirements for medical devices.
Experience in risk management, CAPA processes and quality audits.
Strong communication skills and experience in liaising with authorities and implementing regulatory requirements.
Ability to train employees in quality topics and continuously improve the QM system.
Fluent written and spoken in German and English
20 hours of time per week
Nice to have: Experience with breast cancer

Why us?

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

Contact information

Ms. Ana Rivas Molina

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About us

Sidekick Health is a global pioneer in digital health and therapeutics and is committed to transforming patient-centred care through innovative solutions. Founded by two physicians, the company offers a diverse range of digital health programmes covering a variety of therapeutic areas from oncology, cardiovascular diseases, metabolic disorders and inflammatory diseases.

In 2023, Sidekick Health acquired the aidhere GmbH (now Sidekick Health Germany GmbH) as its third division - in addition to its cooperation with world-renowned pharmaceutical companies and the largest health insurance company in the USA - for prescription-capable digital therapeutics. Sidekick Health Germany is the market leader in the field of digital health applications (DiGA) and has already helped more than 40,000 people to lose weight with its first product zanadio, a digital, multimodal obesity therapy.

Sidekick is headquartered in Reykjavik and Hamburg and employs over 250 people worldwide.

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Wir freuen uns auf dich!

Wir freuen uns über dein Interesse an der Sidekick Health Germany GmbH. Bitte fülle das folgende Formular kurz aus. Solltest du Schwierigkeiten mit dem Upload deiner Daten haben, wende dich gerne per Email an rxjobs@sidekickhealth.com