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Product Creation Quality Assurance Specialist

2 weeks ago

Copenhagen, Copenhagen, Denmark 3Shape AS Full time

Company Overview:

3Shape A/S is an exciting, visionary, and international company to work for.

We are a diverse group of over 50 different nationalities who all contribute to an awesome company culture.

Our company culture makes Monday mornings worth it.

About the Role:

As a Quality Assurance Specialist in the System Integration group, you will be actively involved in ensuring delivery of development projects.

You will ensure that our scanner systems meet the standards of quality and compliance.

In your daily work, you will collaborate with a variety of different colleagues to develop optical scanner systems.

Responsibilities:

  • Quality assurance in development projects
  • Conducting document and project reviews
  • 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

Requirements:

To succeed in this role, you will need experience quality assurance in medical device product development.

You must have knowledge and experience in ensuring compliance with ISO 13485, ISO 14971, IEC 62304, IEC 60601, IEC 62366, MDR, and 21 CFR Part 820, GDP, GMP.

What We Offer:

We offer 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.