Quality Management System Specialist

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.