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.
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)
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