Quality Assurance Manager

Quality Manager Do you want to join a world leading dental company that´s been shaping the industry around the world for more than a century? With our innovative solution we improve oral health worldwide. We make people smile!   Join us at our Dental Sirona Implants in Mölndal / Gothenburg.   What are we expecting from you? As Quality Manager you will work in a Global Environment and be part of a cross functional team. The main objective for the position is to secure Quality Assurance for critical quality system processes such as CAPA, Non Conformities and Supplier Management. You will work in close collaboration with other sites in the Dentsply Sirona organization.   Responsibilities: Global NC process owner, providing support both locally and globally Global CAPA process owner, providing support both locally and globally Global Supplier Controls process owner Core member hosting external audits and inspections Take the Lead and coordinate Non-conformity / CAPA activities Lead root cause investigations related to Quality Issues Actively work with Continuous Improvements of the Quality system procedures and SOP’s Participate as QA representative in improvement projects   Background / Qualifications: An academic degree in engineering or equivalent professional background and more than 5 year’s experience from the medical device industry. Skilled knowledge of US FDA 21 CFR Part 820 – Quality System Regulation Skilled knowledge ISO 13485:2016 Medical Devices – Quality Management Systems EU’s Regulation (EU) 2017/745 on medical devices, also known as EU Medical Device Regulation Excellent communication skills as the role requires close contact with several functions and stakeholders. Good knowledge and experience from Notified Body Audits and/or FDA Inspections. Full command in English, both written and spoken.   Personal characteristics are planning skills, attention to details and the skill to lead a team. We believe that you are a positive and social person with the ability to maintain a good relationship with local and global stakeholders. It is an advantage if you have strong focus and drive to achieve goals and targets.