Denmark Job Openings

3Shape

Quality Assurance Specialist

Copenhagen

August 12, 2024

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.
You will work with colleagues across R&D, product development, scientific management, product management, and production, and from our locations in Denmark, Poland and Ukraine.
Your tasks include:

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

Join us in shaping a company culture that makes Monday mornings worth it
We are an exciting, visionary, and international place to work. But most of all, we are a diverse group of over 50 different nationalities who all contribute to an awesome company culture. We partake in social clubs, monthly Friday social activities, as well as various in-team activities. If that’s not enough, then add on:

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.

Due to summer vacations we will start getting back to candidates at the beginning of August.

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.
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 Linked In.

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