QA Specialist Product Creation · DK - Copenhagen

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.

As a Quality Assurance Specialist in 3Shape, you will be actively involved in ensuring delivery of development projects, and ensuring that our scanner systems meet the standards of quality and compliance.

You will in your daily work be allocated to development projects but will also work on general system development and systems integration tasks such as streamlining processes within the department.

In a normal workday you will collaborate with a variety of different colleagues to develop optical scanner systems.

You will be part of the System Integration group covering design verification and validation, usability and risk management. The team currently has 7 people – all engaged in their work and with good humor. The team is closely related to our sister team Systems and Architecture.

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.

About you:

• Experience quality assurance in medical device product development
• Experience with design control, CAPA, change control and non-conformities
• Detail oriented
• 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
• Ability to address complex matters and take tough decisions
• You like working in teams and have a practical and pragmatic approach
• Experience with supporting 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.

Get in touch now!
If you are interested in this opportunity, apply today. We will review applications continuously.

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.

Department
Product Creation

Role
TRIOS & Scanner

Locations
DK - Copenhagen

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