3Shape Poland Sp. z o.o.

is looking for

Quality Management System Specialist

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 two years of experience in QMS, preferably in an international organization
  • Previous experience in a highly regulated industry (e.g. medical device, pharma, automotive)
  • Experience in FDA, GMP, ISO 13485 would be an advantage
  • Experienced in third party audits and inspections would be an advantage
  • Fluent English (Polish is an advantage)
  • Ready to learn and to share your knowledge
  • Organized, flexible, communicative
  • Can work with minimum supervision

Your Responsibility:

  • Active part in the standardization processes across global organisation
    in Poland, Denmark, US and China – Global QMS
  • Daily work with QMS Documentation
  • Conducting Internal audits and support during external audits
    and inspections (Poland and Denmark)
  • Cooperation with all departments across the organization
  • Active participation in the projects related to the Quality Management System
  • Strong 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 27 C, 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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Reference No.:

MRI

Region:

  • zachodniopomorski

Job type:

Regular

Working hours:

Full-time

Working days:

Day

Location:

Szczecin

Contacts:

Magdalena Giba

Company homepage:

http://www.3shape.com

Office address: