Global Quality Management System Manager
Join our amazing and unique QMS team!
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.
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)
We 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
We will be glad to welcome you in our team!
Please note that only resumes in English will be considered
- Department
- Quality
- Locations
- PL - Szczecin
PL - Szczecin
Our biggest assets are our people and culture 💗
Life at 3Shape is great! We bring passion and talent to work every day to innovate for superior patient care. 3Shape is built on a culture of thinking differently and being innovative when solving challenges. We embrace new ways to exchange ideas with colleagues across departments and think and work in an agile way. Experience the everyday #lifeat3Shape across the globe on Facebook.
About 3Shape
3Shape develops 3D scanners and software solutions that enable dental and hearing professionals to treat more people, more effectively and with superior care. We are a global market-leading provider of dental and audio technology for laboratories and clinics.
Our growing talent pool of over 1,600 employees spans 35+ nationalities and is energized by knowing that together, we contribute to a better world.
Two graduate students founded 3Shape in Denmark’s capital, Copenhagen in the year 2000. Today, 3Shape employees serve customers in over 100 countries. As a privately-owned company, decisions are made fast, and we remain agile.
3Shape is headquartered in Copenhagen, with development teams in Denmark and Ukraine and with a production site in Poland. 3Shape is a global company with presence in Europe, Asia and the Americas. Check out the ratings of 3Shape as employer on Glassdoor.
Global Quality Management System Manager
Join our amazing and unique QMS team!
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