Dentsply Sirona · 23 hours ago
Senior Quality Manager
Johnson City, TN
Full-time
Onsite
Senior Level
5+ years expDentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, committed to advancing patient care. They are seeking a Senior Quality Manager to lead their Quality team, ensuring compliance with medical device regulations and overseeing quality management systems.
DentalEducationHealth CareManufacturingMedical Device
Responsibilities
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
Qualification
Required
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
Company
Dentsply Sirona
Dentsply Sirona is a manufacturer of dental products and technologies.
10001+ employees
H1B Sponsorship
Dentsply Sirona has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (28)
2024 (14)
2023 (7)
2022 (14)
2021 (9)
2020 (16)
Funding
Current Stage
Public CompanyTotal Funding
$550M2025-06-05Post Ipo Debt· $550M
1987-08-21IPO
Leadership Team
Daniel Scavilla
President and Chief Executive Officer
Matthew Garth
Chief Financial Officer
Recent News
GlobeNewswire
2026-01-16
2026-01-16
Company data provided by crunchbase