Internal Auditor for Quality Systems

6 days ago


Helsinki, Uusimaa, Finland Topcon Healthcare Solutions Oy Full time

Ensuring Compliance

We're seeking a skilled and detail-oriented individual to join our team at Topcon Healthcare Solutions Oy. As a Quality Manager, you'll 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, and evaluating suppliers.

Key Qualifications

  • 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.

Collaboration and Communication

As a Quality Manager at Topcon Healthcare Solutions Oy, you'll actively collaborate across different departments within the Company and support their activities to ensure compliance with applicable regulations and standards. You'll also provide training on applicable QMS processes and evaluate suppliers.


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