Dentsply Sirona
Dentsply 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. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY.
This position is located in Tulsa OK, in the heart of Green Country in Northeast Oklahoma, the city of Tulsa is the 2nd largest city in Oklahoma and prides itself on its growing economy, beautiful recreational and scenic destinations, and cultural attractions. Tulsa is a flourishing city with the friendliness and close-knit attitude of a much smaller town. Among the city’s many advantages are choices of a variety of schools, businesses, museums, shopping centers, universities and cultural hotspots, making Tulsa a great place to live, work and raise a family! 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. We are seeking a Quality Assurance Manager to lead our Quality team at the Johnson City site. This is a high-impact role where you will serve as the Site’s Management Representative and the Person Responsible for Regulatory Compliance (PRRC) under EU MDR 2017/745. What You’ll Do: • Lead QA, QE, QC, and Post-Market Surveillance teams, overseeing all QMS activities defined in the quality manual. • Ensure compliance with FDA, ISO 13485, MDSAP, EU MDR and other applicable global medical device standards and regulations. • Provide oversight of sterile medical device manufacturing, including sterilization validation, monitoring, and routine controls. • Manage and support validations and controls in alignment with ISO 11137 (sterilization of healthcare products – radiation) and ISO 11737 (bioburden, sterility testing, endotoxins). • Represent the site in audits, inspections, and top management reviews. • Drive the CAPA process, risk management activities, and continuous improvement of quality systems. • Promote regulatory awareness and provide training across the organization. • Collaborate with R&D, Manufacturing, and RA to ensure quality and compliance across the product lifecycle. What We’re Looking For: • 5+ years of proven experience in Quality Management within the medical device industry • Strong knowledge of sterile medical device requirements and sterilization validations (ISO 11137 / ISO 11737 series) • Solid background in ISO 13485, FDA QSR, MDSAP, and EU MDR requirements • Leadership skills to guide and grow cross-functional quality teams • Hands-on experience with CAPA, audits, and risk management
This position is located in Tulsa OK, in the heart of Green Country in Northeast Oklahoma, the city of Tulsa is the 2nd largest city in Oklahoma and prides itself on its growing economy, beautiful recreational and scenic destinations, and cultural attractions. Tulsa is a flourishing city with the friendliness and close-knit attitude of a much smaller town. Among the city’s many advantages are choices of a variety of schools, businesses, museums, shopping centers, universities and cultural hotspots, making Tulsa a great place to live, work and raise a family! 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. We are seeking a Quality Assurance Manager to lead our Quality team at the Johnson City site. This is a high-impact role where you will serve as the Site’s Management Representative and the Person Responsible for Regulatory Compliance (PRRC) under EU MDR 2017/745. What You’ll Do: • Lead QA, QE, QC, and Post-Market Surveillance teams, overseeing all QMS activities defined in the quality manual. • Ensure compliance with FDA, ISO 13485, MDSAP, EU MDR and other applicable global medical device standards and regulations. • Provide oversight of sterile medical device manufacturing, including sterilization validation, monitoring, and routine controls. • Manage and support validations and controls in alignment with ISO 11137 (sterilization of healthcare products – radiation) and ISO 11737 (bioburden, sterility testing, endotoxins). • Represent the site in audits, inspections, and top management reviews. • Drive the CAPA process, risk management activities, and continuous improvement of quality systems. • Promote regulatory awareness and provide training across the organization. • Collaborate with R&D, Manufacturing, and RA to ensure quality and compliance across the product lifecycle. What We’re Looking For: • 5+ years of proven experience in Quality Management within the medical device industry • Strong knowledge of sterile medical device requirements and sterilization validations (ISO 11137 / ISO 11737 series) • Solid background in ISO 13485, FDA QSR, MDSAP, and EU MDR requirements • Leadership skills to guide and grow cross-functional quality teams • Hands-on experience with CAPA, audits, and risk management