Oferta: Senior Quality Management System Specialist

Senior Quality Management System Specialist
Miejsce pracy: Szczecin

3Shape started with a simple idea - to make 3D scanning better. First, we applied it to the hearing industry, then we succeeded in dentistry. Now, twenty years later, 3Shape is 1,600+ 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.

 

We are now looking for Senior Quality Management System Specialist to provide the best assist to our business partners.

Our offer:
  • Work in an inspiring environment with social, knowledgeable and experienced colleagues
  • A job with good work-life balance
  • Part of global leading fast-growing company
  • Lunch for 2 pln in our canteen
  • Personal growth and development
  • Friendly and supportive colleagues that are fun to spend time with
  • Private healthcare with dental treatment and cafeteria benefit system to keep you fit and wel
Your Profile: 
  • Quality mindset with business approach 
  • At least five years of experience in QMS in medical device organization 
  • 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 Experienced 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 independently, with minimum supervision

 

Your Responsibility:
  • Develop Global QMS covering Poland, Denmark, US, UA 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 locations 
  • Cooperate with all departments across the organization in implementing new/updated regulations 
  • Active participation in the projects related to the Quality Management System
  • Close cooperation with Danish Headquarter
Your Profile: 
  • Quality mindset with business approach 
  • At least five years of experience in QMS in medical device organization 
  • 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 Experienced 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 independently, with minimum supervision

 

Your Responsibility:
  • Develop Global QMS covering Poland, Denmark, US, UA 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 locations 
  • Cooperate with all departments across the organization in implementing new/updated regulations 
  • Active participation in the projects related to the Quality Management System
  • Close cooperation with Danish Headquarter
Please add consent for processing personal data included: In accordance with the Law of Personal Data Protection of 29.08.1997 (Journal of Laws No. 133, item 883) I give my consent to processing of my personal data contained in my application for the purpose of current and future recruitment process within 3Shape Group.In accordance with art. 24 sec. 1 of the Act of 29 August 1997 on the Protection of Personal Data (Journal of Laws of 2002, No. 101, item 926, as amended), we inform you that the administrator of personal data provided by you voluntarily to conduct current and future recruitment is 3Shape Poland Sp. z o. o. with headquarters in Szczecin 71-001, at Południowa 27C. You have the right to access, correct and delete your personal data. Please be advised that, apart from the entities authorized under the law, the collected personal data will not be made available. Your personal data will be kept for a period of 12 months.Please be informed 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.
APLIKUJ TERAZ

Szczegóły oferty
Stanowisko: Senior Quality Management System Specialist
Firma: 3SHAPE POLAND SP. Z O.O.
Miejsce pracy: Szczecin
Opublikowano: 2021-04-16