Quality Manager für Berlin gesucht
Arbeits- und Stellenangebot im Regiobizz Arbeitsmarkt
Job Kategorie: IT/IT-Dienstleistung Informationstechnologie (IT)
Stellenangebot Basisdaten
- Arbeitsort:
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DE 10407 Berlin
- Umkreis:
-
keine Angabe.
- Art der Arbeitsstelle:
-
- Letze Aktualisierung:
-
26.09.20242024-09-26
Stellenausschreibung: Quality Manager
- Arbeitgeber bzw.
Arbeitsvermittler
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Klenico Health in Hamburg
- Branche
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IT/IT-Dienstleistung
- Kategorie
-
Informationstechnologie (IT)
- Stellenbeschreibung
- Intro Klenico Health AG is a HealthTech company in Zurich and Berlin,
which has set itself the goal of helping people with mental stress or
illness. In cooperation with leading clinics in Europe, we have
developed a web-based, CE-marked medical device software that guides
healthcare professionals through the diagnostic process for mental
disorders. We are currently preparing for the MDR certification
process and are looking for a Quality Manager to support the team and
drive the quality management system activities. The primary work
location is Berlin, with the option to work from home, provided you
are willing to come to the office at least once per week. A valid EU
work permit is required. In addition to full-time employment, a
part-time arrangement (80-100%) is also available. Tasks As the
Quality Manager, you will play a crucial role in ensuring the highest
standards of quality assurance within our organization in accordance
with ISO 13485 and the EU Medical Device Regulation. This position
will be responsible for the following key activities: Manage and
document non-conformities (NCs) and corrective and preventive actions
(CAPAs) Establish and maintain the software file according to IEC
62304 in collaboration with the product team Manage changes to the
quality management system Support internal and external audits,
including preparation and follow-up on audit findings Conduct software
tool validations Support the preparation and execution of management
reviews Oversee and maintain the company’s document management
system Identify and implement opportunities for process improvements
and promote a culture of continuous quality enhancement Requirements
Minimum of 2 years of relevant experience in quality assurance in the
medical device industry Bachelor’s degree in a related field Good
knowledge of ISO 13485, MDR and IEC 62304 Strong understanding of NCs
and CAPA processes Team player Fluent in English Basic command of
German is a plus Benefits Modern office in a coworking hub in Berlin
and Zurich Mental health support offers Regular team events (outdoor
activities, team lunches and aperitifs) Subsidized travel costs for
local public transport in Berlin Freeletics discount Closing We look
forward to your application!
- Qualifikation
- Arbeitskräfte
- Verdienst:
- n.a.
- Bewerbung an
- Klenico Health
Am Strandkai 1
De 20457 Hamburg
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