Quality Management System Manager

3Shape’s business is constantly growing and becoming more and more complex, the same goes
for the production area in 3Shape Poland Sp. z o.o. in Szczecin.

To support this development, we seek a Quality Management System Manager.

Quality Management System led by Global QMS team located in Szczecin, is an integral part
of 3Shape Group functionality and is valid in all locations, all over the world. As a system that documents processes, procedures, and responsibilities for achieving quality policies and objectives, our goal is to continuously improve the effectiveness and efficiency within the company.
QMS helps to coordinate organization activities to meet both customer and regulatory requirements and improve its effectiveness and efficiency on daily basis and based on ISO 13485:2016, FDA 21 CFR 820 and other requirements.

Your Profile

  • At least five years of career path within medical devices sector
  • At least two years of experience in similar manager position with people responsibility
  • Practical experience in ISO13485, FDA and GMP is required
  • Knowledge of UDI system (an advantage)
  • Experience as an internal auditor (Internal Auditor ISO13485)
  • Experience at work in international environment
  • Very good English, both verbally and writing (essential condition)
  • Leadership skills for a team in growth and understanding change management
  • Strong sense of responsibility and communication skills

Your Responsibility:

  • Leading implementation, maintenance and improvement of Global QMS
    across organisation in Poland, Denmark, US and China
  • Leading team of 5-7 subordinates
  • Leading internal audits and preparing company for external audits and inspections
    (Poland and Denmark)
  • Supervision of CAPA and Engineering Change Order systems
  • Supervision of the external and internal documentation
  • Reporting of Quality Management System status
  • Providing training and sharing awareness in the field of QMS within respective departments
  • Cooperation with several departments in all aspects connected with quality assurance
  • Cooperation with Headquarter in Copenhagen, DK (travel around 20-30 days per year)

We offer:

  • 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.
  • Benefit package including English or German classes.
  • Company events.

 We will be glad to welcome you in our team!

 Please note that only resumes in English will be considered




Łukasz Kurzątkowski

Send application


About Us

3Shape is changing dentistry together with dental professionals across the world by developing innovations that provide superior dental care for patients. Our portfolio of 3D scanners and CAD/CAM software solutions for the dental industry includes the multiple award-winning 3Shape TRIOS intraoral scanner, the upcoming 3Shape X1 CBCT scanner, and market leading scanning and design software solutions for dental labs.
Two graduate students founded 3Shape in Denmark’s capital in the year 2000. Today, 3Shape has over 1,200 employees serving customers in over 100 countries from an ever-growing number of 3Shape offices around the world. 3Shape’s products and innovations continue to challenge traditional methods, enabling dental professionals to treat more patients more effectively. www.3shape.com

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 fulfil 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.