Quality Assurance Manager

6 days ago


Helsinki, Uusimaa, Finland Topcon Healthcare Solutions Oy Full time

Company Overview

We are a leading provider of digital healthcare solutions whose vision is to improve access and quality of healthcare while decreasing the cost of care. Our strategy, Healthcare from the Eye, involves applying AI models to imaging data from the eye to facilitate earlier detection and better management of disease.

Job Description

As a Quality Manager at Topcon Healthcare Solutions Oy, you will have an impact on ensuring the delivery of high-quality software products focused on customer needs. Your responsibilities will include acting as an Internal Auditor - ISO 13485:2016, guiding cross-functional teams through the CAPA process, evaluating suppliers, and providing training on applicable QMS processes.

Required Skills and Qualifications

  • A solid understanding and proven working experience with ISO 13485, EU MDR, and 21 CFR §820.
  • Internal auditing certification or proven experience in internal auditing.
  • Hands-on experience in CAPA process.
  • Knowledge of IEC 62304 and ISO/IEC 27001 is seen as an advantage.
  • Strong written and verbal communication skills.
  • Excellent collaboration skills.
  • Well-organized and able to work independently.
  • Fluent written and spoken English skills.

Benefits

You'll enjoy benefits like a lunch allowance, sports, massage, and culture vouchers, and leisure-time insurance, and an education benefit to support your professional development.



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