Quality Assurance Lead
vor 1 Monat
Klenico Health AG is a pioneering HealthTech organization dedicated to enhancing mental health support through innovative solutions.
We have developed a web-based, CE-marked medical device software in collaboration with leading clinics across Europe, aimed at assisting healthcare professionals in the diagnostic process for mental health conditions.
As we prepare for the MDR certification journey, we are seeking a Quality Manager to bolster our team and oversee quality management system initiatives.
The primary work location is in Berlin, with flexible options for remote work, requiring at least one office visit per week. A valid EU work permit is necessary. We offer both full-time and part-time employment arrangements.
Key ResponsibilitiesIn the role of Quality Manager, you will be instrumental in upholding the highest quality assurance standards within our organization, ensuring compliance with ISO 13485 and the EU Medical Device Regulation. Your key responsibilities will include:
- Managing and documenting non-conformities (NCs) and corrective and preventive actions (CAPAs)
- Establishing and maintaining the software file in accordance with IEC 62304 in collaboration with the product team
- Overseeing changes to the quality management system
- Supporting internal and external audits, including preparation and follow-up on audit findings
- Conducting validations of software tools
- Assisting in the preparation and execution of management reviews
- Managing and maintaining the company's document management system
- Identifying and implementing process improvement opportunities while fostering a culture of continuous quality enhancement
- A minimum of 2 years of relevant experience in quality assurance within the medical device sector
- A Bachelor's degree in a related discipline
- Strong knowledge of ISO 13485, MDR, and IEC 62304
- Solid understanding of NCs and CAPA processes
- A collaborative team player
- Fluency in English
- Basic proficiency in German is advantageous
- Modern office environment in a coworking hub
- Mental health support initiatives
- Regular team-building events, including outdoor activities and team lunches
- Subsidized travel costs for local public transport
- Discounts on fitness programs
We look forward to your application.
Visual diagnostics for mental health.
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