Quality Assurance Specialist DK - Copenhagen

About the job
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.

As a Quality Assurance Specialist in 3Shape, you will play an important role in ensuring delivery of development projects, and ensuring that our scanner systems meet the standards of quality and compliance.

Your tasks include:

• Lead quality assurance in a development project
• Contribute to Design Control for our Intra Oral Systems.
• Conducting document and project 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 medical device product development
• Experience with independently driving a quality mindset in medical device projects
• Experience with design control, CAPA, change control and non-conformities
• Detail oriented with independency to act as quality support for the project team
• Knowledge and hands-on experience in ensuring compliance with ISO 13485, ISO 14971, IEC 62304, IEC 60601, IEC 62366, MDR, and 21 CFR Part 820, GDP, GMP

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 social activities and various in-team activities as well. 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.
• A joint purpose: to enable dentists to provide superior dental care to every patient, every time.

Staying true to our values and DEI efforts, we encourage all relevant applicants to apply, and we ask you NOT to add any photos or sensitive information (age, marital status, nationality) during the application process.

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 LinkedIn.

Locations
DK - Copenhagen

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