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Quality Assurance Expert

2 months 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

Why 3Shape?

  • 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
  • Amazing location – our office is located in the heart of Copenhagen, right next to Kongens Nytorv
  • A joint purpose: to enable dentists to provide superior patient care to every patient, every time