Quality Management System Manager
We are currently looking for a Quality Management System Manager who will join our team in Szczecin. This key role is vital in ensuring that everything we do meets our company standards and exceeds customer expectations. The position blends technical expertise with strategic leadership and leading a team of QMS Specialists. As the manager, you will provide mentorship, set performance goals, and foster a collaborative environment to enhance the global management system. Responsibilities span key areas such as Quality Compliance, Auditing, Corrective Action, QMS Certification, and Process Risk Management.
Responsibilities:
Ensuring that processes needed for the Global Quality Management System are established, implemented, and maintained at all 3Shape sites.
Ensure effective implementation and maintenance into the QMS of all requirements, documentation and records relevant to 3Shape scope of operation.
Establish and maintain a framework for close cooperation between the Global QMS team and the process owners and/or other key stakeholders.
Ensure effective knowledge sharing to help the process owners and/or other key stakeholders understand and interpret relevant requirements to implement them into their processes.
Lead, manage and support CAPA & NCR process at all 3Shape locations.
Establish an effective process for collecting data on QMS effectiveness and needs for improvement and ensure proper communication to the top management.
Ensure an effective process for handling external audits and/or inspections and the actions resulting from them, in all locations.
Actions to promote importance of the Global QMS.
Support compliance and quality assurance processes.
Qualifications:
To qualify for the role of a QMS Manager, we hope that you would have:
Bachelor’s or Master’s degree in a relevant field, such as quality management.
5 years of experience in certified management systems in a highly regulated environment. Experience with GMP is an advantage.
Auditor competence and knowledge of ISO 13485 is a big advantage.
Experience in designing, implementing and improving of Quality Systems.
Excellent understanding of quality requirements and regulatory principles within medical device industry (alternatively: automotive, aerospace or pharmaceutical industry).
Strong problem solving skills, focused on effective root cause and corrective actions.
Manager responsible for leading a hybrid team, with ability to work independently and partner with cross‑functional stakeholders.
Great interpersonal skills.
Fluent Polish & English.
Experience in working within cross-functional and multi-cultural teams.
We offer:
Attractive office with relax zones located in Szczecin, Poland.
A vibrant and international environment with social, diverse, and highly skilled and cooperative colleagues.
An attractive Luxmed healthcare package with additional dentistry care.
Fresh fruits, delicious and healthy lunches cooked by our canteen.
We provide a great social work environment with many optional activities.
Good work/life balance.
Language courses with qualified teachers.
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.
In compliance with the Whistleblower Protection Act, we inform candidates that an internal whistleblowing channel is available within our organization.
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
- Production & Supply Chain & Quality
- Role
- Global Operations
- Locations
- PL - Szczecin
We are only as strong as the people who join us!
Our employees are our talent, our ambassadors, and the driving force behind our success. They are also our future. Together, they use their passion and spirit for innovation to help build our brand and our reputation, making us a destination for pioneering work and personal career growth.
- Connect with us - get notified with jobs matching your interests
- Follow us on LinkedIn - experience our culture and everyday life from around the globe
Learn More
About 3Shape
3Shape develops 3D scanners and software solutions that enable dental and hearing professionals to treat more people, more effectively and with superior care. We are a global market-leading provider of dental and audio technology for laboratories and clinics.
Our growing talent pool of over 2,000 employees spans 50+ nationalities and is energized by knowing that together, we contribute to a better world.
Two graduate students founded 3Shape in Denmark’s capital, Copenhagen in the year 2000. Today, 3Shape employees serve customers in over 100 countries. As a privately-owned company, decisions are made fast, and we remain agile.
3Shape is headquartered in Copenhagen, with development teams in Denmark, Ukraine and Macedonia with a production site in Poland. 3Shape is a global company with presence in Europe, Asia and the Americas.