Senior QMS Specialist (Poland, Szczecin)

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.

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, MDSAP, MDR 2017/745 and other requirements. 

Your Responsibilities: 

• Develop Global QMS covering Denmark, Poland, the US, Japan, Korea, and China 

• 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 approx. 20-30 days per year)

Your Profile: 

• 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 

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.