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)