Dentsply Sirona · 9 hours ago
Quality Engineer, Microbiological Specialist
Johnson City, TN
Full-time
Onsite
Mid, Senior Level
3+ years expDentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, dedicated to advancing patient care through innovative solutions. The Quality Engineer / Microbiological Specialist will establish and improve validation, sterilization, and microbiological control activities at the Johnson City site, ensuring compliance with applicable standards and driving risk-based improvements to maintain product quality and patient safety.
DentalEducationHealth CareManufacturingMedical Device
Responsibilities
Lead and maintain sterilization validation programs for products sterilized by gamma radiation, ensuring full compliance with ISO 11137-1/-2/-3 and FDA 21 CFR 820.75
Develop and execute sterilization validation protocols (IQ/OQ/PQ) and periodic requalification per the Dentsply Sirona global validation procedure
Manage dose audit and bioburden monitoring programs, analyzing trends and escalating deviations through the QMS
Support supplier qualification and change control related to contract sterilization facilities
Collaborate with R&D and Manufacturing Engineering to ensure new or transferred products are compatible with established sterilization parameters
Lead and maintain test method validations and verifications for microbiological assays (bioburden, sterility, bacterial endotoxins) in compliance with ISO 11737 parts 1, 2 and 3 and USP-NF 2024
Oversee periodic method suitability testing and recovery studies with external laboratories
Review and approve microbiological test reports, ensuring data integrity and traceability in SmartSolve
Evaluate and approve laboratory control changes, ensuring continued suitability for intended use
Own and maintain the environmental monitoring (EM) program for controlled areas and cleanrooms used for product assembly and packaging, ensuring compliance with ISO 14644 and ISO 14698
Review EM trending data, initiate and lead investigations for out-of-limit (OOL) or alert-level events, and ensure CAPAs are properly documented in SmartSolve
Support cleanroom qualification/requalification and pressure cascade verification activities in partnership with Facilities and Engineering
Provide technical guidance to operations on aseptic practices, gowning, and material flow to prevent contamination
Ensure alignment with the Global Quality System (GQS) and local SOPs for sterilization, environmental control, and microbiological testing
Author, review, and maintain SOPs, work instructions, and validation reports related to sterilization and microbiological processes
Represent the site during internal and external audits (FDA, BSI, TÜV, MDSAP) as the sterilization and microbiology SME
Identify opportunities for process improvements, risk reduction, and enhanced contamination control
Work closely with R&D, Manufacturing Engineering, Regulatory Affairs, and Supplier Quality to ensure robust microbiological control throughout the product lifecycle
Support global DS projects involving sterilization or microbiological validation
Provide technical training and mentoring for manufacturing and quality teams on sterilization and microbiological principles
Serve as the site owner for equipment and process validation activities across all manufacturing and supporting processes, in alignment with ISO 13485:2016, 21 CFR 820.70 / 820.75, and Dentsply Sirona’s Global Validation Policy
Develop, execute, and maintain validation protocols (IQ/OQ/PQ) for production and laboratory equipment, utilities, and automated systems used in manufacturing, packaging, or testing
Partner with Engineering and Manufacturing to ensure new or modified processes are validated before release for routine production
Ensure validation master plans, schedules, and revalidation requirements are up to date and aligned with global QA standards
Lead or support process characterization, risk assessments, and statistical capability studies (CpK, Ppk) during validation planning and execution
Review and approve validation documentation prepared by other functions to ensure consistency, technical adequacy, and regulatory compliance
Maintain validation traceability and control through SmartSolve or other designated QMS systems
Act as the primary site interface for internal and external audits regarding validation programs, ensuring readiness and documentation integrity
Provide technical guidance and training to engineers and production teams on validation principles, documentation, and lifecycle management
Qualification
Required
Bachelor's or Master's degree in Microbiology, Biology, Biomedical/Quality Engineering, or a related discipline is preferred, or an equivalent combination of experience and education
3–5+ years of experience in sterilization validation and microbiological quality systems in the medical device or pharmaceutical industry
Strong knowledge of ISO 13485, ISO 11137, ISO 11737, ISO 14644, and FDA 21 CFR 820
Experience with gamma sterilization validation and environmental control programs required
Strong analytical, documentation, and cross-functional communication skills
Understanding of Good Manufacturing Practices, Quality Systems, Regulatory requirements, validation principles and manufacturing methods in Medical Device regulated environment
Understanding of inputs, outputs, raw materials, waste, quality control, costs, and techniques for maximizing the manufacture and distribution of goods
Creative problem solving, flexibility and sound negotiation skills
Strong project management skills as well as an ability to multi-task
Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry helpful
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations
Ability to analyze, estimate and evaluate data
Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems
Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.) in its most difficult phases
Ability to deal with a variety of abstract and concrete variables
Ability to read, analyze and interpret common scientific and technical journals, financial reports and legal documents
Ability to write reports, business correspondence and procedure manuals
Ability to respond internally to common inquiries or complaints from customers, regulatory agencies, or members of the business community
Ability to effectively present information to top management, groups and/or boards of directors
Preferred
Six Sigma is preferred
American Society of Quality – Engineer preferred
Professional Engineering Certificate preferred
Hands-on experience with SmartSolve, TrackWise, or equivalent electronic QMS preferred
Benefits
Health (3 options)
Dental (provided)
Vision
Life (provided) + extra life
Short-term and long-term disability (provided)
401k (retirement) with company matching
10 holidays and paid time off
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