Dental Systems Quality Assurance Specialist

20 hours ago


Copenhagen, Copenhagen, Denmark 3Shape Full time

About the role

We are seeking a skilled Quality Assurance Specialist to contribute to developing dental systems, combining hardware and software components. This specialist will work on improving the quality aspect in our development projects as part of a cross-functional team.

You will collaborate with colleagues from R&D, product development, scientific management, product management, and production teams located in Denmark, Poland, and Ukraine.

Your tasks include:

  • Leading quality assurance in a development project
  • Contributing to Design Control for intraoral systems
  • Conducting reviews and supporting risk management
  • Providing guidance during root cause analysis
  • Supporting the completion of CAPA's with the Quality and RD organization
  • Supporting, reviewing, and improving 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

Company Overview

3Shape is an innovative company that started with a simple idea - to make 3D scanning better. With over 2,000 employees globally, we're creating award-winning scanning and CAD/CAM solutions to change dentistry together.

Benefits

  • An attractive healthcare package to keep you fit and well
  • Breakfast every day, and a delicious and healthy lunch cooked by our private chefs
  • Good work/life balance e.g., work from home policy for up to 2 days per week
  • A joint purpose: to enable dentists to provide superior patient care to every patient, every time

Working at 3Shape

We encourage all relevant applicants to apply. We are committed to celebrating human diversity, and we trust that the best way to reach outstanding business results is by welcoming diverse people into our community.



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