Dentsply Sirona
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Sr QA Manager
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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. This position is located in Tulsa, OK. 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. Job Description
We are seeking a Quality Assurance Manager to lead our Quality team at the Tulsa Dental Specialties 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 Dentsply Sirona is an Equal Opportunity/ Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, or protected Veteran status. If you need assistance with completing the online application due to a disability, please send an accommodation request to careers@dentsplysirona.com.
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Sr QA Manager
role at
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. This position is located in Tulsa, OK. 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. Job Description
We are seeking a Quality Assurance Manager to lead our Quality team at the Tulsa Dental Specialties 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 Dentsply Sirona is an Equal Opportunity/ Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, or protected Veteran status. If you need assistance with completing the online application due to a disability, please send an accommodation request to careers@dentsplysirona.com.
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