Quality Assurance Specialist

4 weeks ago


Copenhagen, Copenhagen, Denmark 3Shape Full time
About the Role

We are seeking a Quality Assurance Specialist to contribute to developing scanner systems, a combination of hardware and software systems in the medical device domain. You will work on improving the quality aspect in our development projects as part of a cross-functional team.

Your Responsibilities
  • Lead quality assurance in a development project
  • Contribute to Design Control for our Intra Oral Systems
  • Conducting reviews and support risk management
  • Guidance during root cause analysis
  • Support the completion of CAPA's with our Quality and RD organization
  • Support, review, and improve the Technical File documentation process
Your Profile
  • Knowledge of quality assurance in a product development context
  • Experience with design control, CAPA, change control, and non-conformities
  • Knowledge and hands-on experience in ISO 13485, ISO 14971, IEC 62304, IEC 60601, IEC 62366, MDR, and 21 CFR Part 820, GDP, GMP
  • Ability to address complex matters and take tough decisions
  • You like working in teams and have a hands-on approach
  • Experience from working with Document Management Systems and audits (external and internal) is beneficial
About Us

3Shape started with a simple idea - to make 3D scanning better. First, we applied it to the hearing industry, then we succeeded in dentistry. Twenty years later, 3Shape has 2,000+ employees globally. With the help of dental professionals and amazing colleagues, we're creating award-winning scanning and CAD/CAM solutions to change dentistry together. Together, we contribute to a better world.

Experience the everyday #lifeat3Shape across the globe on LinkedIn.



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