Quality Manager

at  Klenico Health

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

We look forward to your application

• 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 enhancemen