Quality Audit Specialist

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 three 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 Internal Auditor
  • Experienced in third party audits and inspections
  • Fluent english (polish is an advantage)
  • Ready to learn and to share your  knowledge
  • Organized, flexible, communicative
  • Can work with minimum supervision

 Your Responsibility:

  • Developing Quality Audit process in Global QMS - Poland, Denmark, US and China
  • Recruiting new Internal Quality Auditors  and providing relevant trainings
    in all 4 locations
  • Managing global Internal Quality Audit Plan 
  • Supporting Management and colleagues during external audits and inspections
    in all 4 locations
  • Managing CAPAs related to internal and external audits and inspections
  • 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 70-033, at Zapadła 8d, 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.

Location

Szczecin

Contacts

Magdalena Giba

Send application

http://www.3shape.com

About Us

3Shape is changing dentistry together with dental professionals across the world by developing innovations that provide superior dental care for patients. Our portfolio of 3D scanners and CAD/CAM software solutions for the dental industry includes the multiple award-winning 3Shape TRIOS intraoral scanner, the upcoming 3Shape X1 CBCT scanner, and market leading scanning and design software solutions for dental labs.
Two graduate students founded 3Shape in Denmark’s capital in the year 2000. Today, 3Shape has over 1,500 employees serving customers in over 100 countries from an ever-growing number of 3Shape offices around the world. 3Shape’s products and innovations continue to challenge traditional methods, enabling dental professionals to treat more patients more effectively. www.3shape.com

Working at 3Shape

Become part of an international success, financially as well as product wise. As an employee, you have plenty of room to both make a difference and fulfil personal ambitions in a very knowledge intensive and challenging environment.

3Shape Technology

Through the relentless drive for new digital innovation by 3Shape, we claim to be the most extensive and versatile CAD/CAM system on the market.

3Shape - a Global Company

3Shape is headquartered in Copenhagen, with development teams in Denmark as well as in the Ukraine and with a production site in Poland. 3Shape is a global company with presence in Europe, Asia and the Americas.

Our People

Employing and developing the right people is an important key to 3Shape's success. We want to be the best within our business, an ambition which has created a true fighting spirit throughout the company - with lots of commitment and courage, and a professional attitude towards business.