3Shape: An exciting, visionary, and international place to work
Join one of the most exciting Danish tech companies in the medical device industry and make an impact. With us you will be able to work on solutions used by thousands of dental professionals worldwide. We are currently looking for a (Senior) QMS Specialist who will join our team in Szczecin.
Responsibilities:
• Critical thinking and problem-solving mindset
• At least five years of experience in QMS in medical device organization
• Solid knowledge of ISO 13485, MDSAP, MDR 2017/745 requirements
• Possibility to interpret standards and regulatory requirements into policies and procedures
• Experience with third-party audits and inspections
• Experienced Lead Auditor
• Experience with cross-functional and cross-site projects related to QMS
• Fluent in English (Polish is an advantage)
• Ready to learn and share your knowledge
• Organized, flexible, communicative
• Can work with minimum supervision
Your Responsibility:
• Develop Global QMS covering multiple sites
• Ensuring the fulfillment of the QMS regulatory requirements in the Organization
• Maintenance of CAPA process
• Conduct Internal Audits
• Perform QMS training
• Help other departments understand and interpret regulations
• Support Management and colleagues during external audits and inspections in all locations
• Cooperate with all departments across the organization in implementing new/updated regulation
• Strong cooperation with Danish Headquarter (travel to Denmark 20-30 days per year).
We offer:
- Attractive office with relax zones located in Szczecin, Poland.
- A vibrant and international environment with social, diverse, 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.
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.
