WPISZ SŁOWA KLUCZOWE

Global Quality Management System Manager

Global Quality Management System Manager
Miejsce pracy: Szczecin

Over the past 10 years, 3Shape has successfully launched several revolutionary optical 3D scanner products, serving the dental restoration industry. To support this development, we are looking for an experienced Quality Management System Manager who will report directly to Quality Director.

 

QMS team is located in Szczecin and supports 3Shape worldwide to maintain compliance with all applicable quality and regulatory standards. 3Shape QMS is certified with MDSAP and MDR.

 

Our offer:
  • Becoming part of fantastic QMS Team with highly professional, engaged, and supportive people
  • Flexible working scheme with home office possibility
  • Lots of interesting challenges that will develop you professionally and personally
  • Work in friendly and supportive environment
  • Private medical care (for employees and family members
  • An attractive site location with lunch for 2pln in canteen with observation deck and relax room
Your Profile
  • At least five years of experience in QMS in an international organization in medical device industry
  • At least two years of experience in managerial position
  • Quality mindset with business approach
  • Experienced in FDA inspections and NB audits
  • Solid knowledge of MDD, ISO 13485, FDA 21 CFR 820 (knowledge of MDR, MDSAP and IEC 62304 is an advantage)
  • Experienced in managing cross functional and cross site projects related to QMS
  • Fluent in English (Polish is an advantage)
  • Ready to learn and to share your knowledge
  • Organized, flexible, communicative
  • Can work with minimum supervision
Your Responsibility:
  • Implementation, maintenance, and improvement of Global QMS across organisation (in Poland, Denmark, US, China and other locations)
  • Leading team of 5 highly skilled professionals
  • Liaising with NB, auditing organizations and state authorities
  • Supervision of the following processes: CAPA, service suppliers management, management reviews, documentation management, processes risk management, QMS change evaluation and notification to NB, internal and external audits and inspections
  • Providing gap assessments to the organization for newly introduced standards and regulations
  • Reporting Quality Management System status to Quality Director and Management Representative
  • Providing QMS trainings and awareness to the organization
  • Close cooperation with Headquarter in Copenhagen, DK (travel around 20-30 days per year)
Your Profile
  • At least five years of experience in QMS in an international organization in medical device industry
  • At least two years of experience in managerial position
  • Quality mindset with business approach
  • Experienced in FDA inspections and NB audits
  • Solid knowledge of MDD, ISO 13485, FDA 21 CFR 820 (knowledge of MDR, MDSAP and IEC 62304 is an advantage)
  • Experienced in managing cross functional and cross site projects related to QMS
  • Fluent in English (Polish is an advantage)
  • Ready to learn and to share your knowledge
  • Organized, flexible, communicative
  • Can work with minimum supervision
Your Responsibility:
  • Implementation, maintenance, and improvement of Global QMS across organisation (in Poland, Denmark, US, China and other locations)
  • Leading team of 5 highly skilled professionals
  • Liaising with NB, auditing organizations and state authorities
  • Supervision of the following processes: CAPA, service suppliers management, management reviews, documentation management, processes risk management, QMS change evaluation and notification to NB, internal and external audits and inspections
  • Providing gap assessments to the organization for newly introduced standards and regulations
  • Reporting Quality Management System status to Quality Director and Management Representative
  • Providing QMS trainings and awareness to the organization
  • Close cooperation with Headquarter in Copenhagen, DK (travel around 20-30 days per year)
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.

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