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Quality Assurance Specialist

3 weeks ago

Copenhagen, Copenhagen, Denmark 3Shape Full time

About the Role

At 3Shape, we're seeking a skilled Quality Assurance Specialist to contribute to the development of scanner systems in the medical device domain. As part of our cross-functional team, you'll focus on improving the quality aspect in our development projects.

You'll work closely with colleagues across R&D, product development, scientific management, product management, and production from various locations worldwide.

  • Lead quality assurance in development projects
  • Contribute to Design Control for Intra Oral Systems
  • Review and support risk management activities
  • Guide root cause analysis processes
  • Support CAPA completion with the Quality and RD organization
  • Improve Technical File documentation processes

Your Profile

  • Knowledge of quality assurance in product development
  • Experience with design control, CAPA, change control, and non-conformities
  • Familiarity with ISO 13485, ISO 14971, IEC 62304, IEC 60601, IEC 62366, MDR, and 21 CFR Part 820 regulations
  • Ability to address complex issues and make informed decisions
  • Team-oriented mindset with a hands-on approach
  • Document Management System experience and audit skills are beneficial

Join us in shaping a company culture that fosters collaboration and innovation. We're an international community of over 50 nationalities working together to create award-winning solutions for the dental industry. Enjoy a diverse range of benefits, including:

  • An attractive healthcare package
  • Daily breakfast and healthy lunch options prepared by our private chefs
  • A flexible work-life balance with remote work opportunities
  • An amazing location in Copenhagen's heart
  • A shared purpose: empowering dentists to deliver exceptional patient care