Quality Assurance Specialist

Vor 7 Tagen

Berlin, Berlin, Deutschland Klenico Health Vollzeit
About Klenico Health

Klenico Health AG is a HealthTech company that specializes in developing innovative medical device software solutions to support healthcare professionals in diagnosing mental disorders.

We are committed to delivering high-quality products that meet the stringent regulatory requirements of the EU Medical Device Regulation (MDR) and ISO 13485 standards.

Job Summary

We are seeking a highly skilled Quality Assurance Specialist to join our team and drive the quality management system activities. As a key member of our organization, you will play a crucial role in ensuring the highest standards of quality assurance and regulatory compliance.

Key Responsibilities
  • Quality Management System
    • 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
  • Regulatory Compliance
    • 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
  • Document Management
    • 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
  • Mental health support offers
  • Regular team events (outdoor activities, team lunches, and aperitifs)
  • Subsidized travel costs for local public transport
  • Freeletics discount

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