3Shape Poland Sp. z o.o.

is looking for

Quality Expert

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

  • Quality mindset with business approach
  • At least five years of experience in QMS in an international organization
    (medical device industry)
  • Experience with FDA Inspections, NB audits
  • Solid knowledge of MDD/MDR, ISO 13485, FDA 21 CFR 820, MDSAP
    (knowledge of IEC 62304 is an advantage)
  • Experienced Lead Auditor
  • Experience in managing cross functional and cross site projects related to QMS
  • Fluent English (Polish is an advantage);
  • Ready to learn and to share your knowledge
  • Organized, flexible, communicative
  • Can work with minimum supervision 

Your Responsibility:

  • Develop Global QMS covering Poland, Denmark, US and China
  • Prepare gap analysis for processes and procedures vs. applicable regulations
  • Conduct Internal Audits
  • Conduct QMS trainings
  • Help other departments to understand and interpret regulations
  • Support Management and colleagues during external audits and inspections in all 4 locations
  • Cooperate with all departments across the organization in implementing
    new/updated regulations
  • Active participation in projects related to the Quality Management System
  • Close cooperation with Danish Headquarter (travel to Denmark approx. 20-30 days per year)

We offer:

  • Lots of interesting challenges that will develop you professionally
  • Personal growth and development
  • Work in professional, friendly and supportive environment
  • Private healthcare and Multisport card to keep you fit and well
  • English or German classes
  • Seasonal parties to keep you connected with colleagues

 We will be glad to welcome you in our team!

 Please note that only resumes in English will be considered.

Please add consent for processing personal data:

“I agree to process my personal data for current recruitment procedure in accordance with article 6 item 1 lit. "a" of the Regulation of the European Parliament and of the Council (EU) 2016/679 of 27th of April 2016 on the protection of individuals with regard to the processing of personal data and on the free movement of such data and repealing Directive 95/46 / EC (General Data Protection Regulation).”

If you would like that your CV is placed in 3Shape recruitment data base for future recruitment, please add second clause in your CV: “I agree to process my personal data for future recruitment procedures as well”.

In accordance with provisions of GDPR please be informed that the data controller in this case is 3Shape Poland Sp. z o. o. with headquarters in Szczecin 71-001, at Południowa 27C, but your application may be proceeded within the 3Shape Group. Your personal data will be used only for purpose related to the recruitment procedures and will be kept in our database for a period of 12 months. More information about proceeding of your personal data by 3Shape you may find here or contacting local HR Department.

Please be informed, in case of interview in our company, that the 3Shape Poland Sp. z o. o. uses closed circuit television (CCTV) images to provide a safe and secure environment for employees and for visitors to the 3Shape Poland Sp. z o. o. business premises as well as to protect the 3Shape Poland Sp. z o. o. property and assets. The CCTV system may be used to investigate security incidents in order to secure evidence, should such incidents occur. All footage gathered is stored no longer than 30 days. The images that are filmed are recorded centrally and held in a secure location.


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  • zachodniopomorski

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Magdalena Giba

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