3Shape’s business is constantly growing and becoming more and more complex, the same goes for the production in 3Shape Poland Sp. z o.o. in Szczecin.
To support this development, we seek a Quality Management System Specialist
- At least two years of relevant experience in QMS
- Previous experience in ISO13485 is required
- Experience in FDA, GMP and UDI system (an advantage)
- Experience as an internal auditor (Certified Internal Auditor ISO13485)
- Experience with external ISO13485 audits or FDA inspection will be an advantage
- Very good English, both verbally and writing (essential condition);
- Good knowledge Excel and PowerPoint
- You pay attention to details together with an analytical way of thinking
- Organized, flexible, communicative
- Active part in the standardization processes across global organisation in Poland, Denmark, US and China – Global QMS
- CAPA and Engineering Change Order systems work with
- Internal audits and team work within external audits and inspections (Poland and Denmark)
- Creation of quality documentation
- Cooperation with several departments in all aspects connected with quality assurance
- Active participation in the projects related to the Quality Management System
- Cooperation with Denmark Headquarter (travel max. around 20-30 days per year)
- Job in a leading global Company.
- Participation in creating market-leading technology products for customers around the world.
- Lots of interesting challenges that will require your technical, analytical and communicative skills.
- Personal growth and development.
- Work in unique professional, friendly and supportive environment.
- English or German classes.
- Company events.
About Us
3Shape A/S is a Danish company specializing in the development and marketing of 3D scanners and CAD/CAM software solutions for the use, creation, processing, analysis and management of high quality 3D data.
Working at 3Shape
Become part of an international success, financially as well as product wise. As an employee, you have plenty of room to both make a difference and fulfill personal ambitions in a very knowledge intensive and challenging environment.
3Shape Technology
Through the relentless drive for new digital innovation by 3Shape, we claim to be the most extensive and versatile CAD/CAM system on the market.
3Shape - a Global Company
3Shape is headquartered in Copenhagen, with development teams in Denmark as well as in the Ukraine and with a production site in Poland. 3Shape is a global company with presence in Europe, Asia and the Americas.
Our People
Employing and developing the right people is an important key to 3Shape's success. We want to be the best within our business, an ambition which has created a true fighting spirit throughout the company - with lots of commitment and courage, and a professional attitude towards business.