Quality Assurance Manager

Requistion ID: 81589Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Dentsply Sirona’s products provide innovative, high-quality and effective solutions to advance patient care and deliver better and safer dentistry. Dentsply Sirona’s global headquarters is located in Charlotte, North Carolina, USA. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY.Bringing out the best in people As advanced as dentistry is today, we are dedicated to making it even better. Our people have a passion for innovation and are committed to applying it to improve dental care. We live and breathe high performance, working as one global team, bringing out the best in each other for the benefit of dental patients, and the professionals who serve them. If you want to grow and develop as a part of a team that is shaping an industry, then we’re looking for the best to join us.Quality ManagerDo 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.ResponsibilitiesGlobal NC process owner, providing support both locally and globallyGlobal CAPA process owner, providing support both locally and globallyGlobal Supplier Controls process ownerCore member hosting external audits and inspectionsTake the Lead and coordinate Non-conformity / CAPA activitiesLead root cause investigations related to Quality IssuesActively work with Continuous Improvements of the Quality system procedures and SOP’sParticipate as QA representative in improvement projectsBackground / QualificationsAn 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 RegulationSkilled knowledge ISO 13485:2016 Medical Devices – Quality Management SystemsEU’s Regulation (EU) 2017/745 on medical devices, also known as EU Medical Device RegulationExcellent 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.Good to knowPlease note that we will review applications continuously, so be sure to send in your application as soon as possible.We look forward hearing from you!