Quality Engineer, Microbiological Specialist
Listed on 2026-01-12
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Quality Assurance - QA/QC
Quality Engineering
Quality Engineer, Microbiological Specialist
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.
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.
Working at Dentsply Sirona you are able to:
Develop faster – with our commitment to the best professional development.
Perform better – as part of a high-performance, empowering culture.
Shape an industry – with a market leader that continues to drive innovation.
Make a difference – by helping improve oral health worldwide.
Our Johnson City, TN Location is looking for someone to join our team as a Quality Engineer / Microbiological Specialist.
We offer competitive wages and a full menu of benefits including 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.
SCOPEThe Quality Engineer / Microbiological Specialist is responsible for establishing, maintaining, and continuously improving all validation, sterilization, and microbiological control activities at the Johnson City site.
This role serves as the site Subject Matter Expert (SME) for gamma sterilization, microbiological testing, environmental monitoring, and equipment and process validation across all manufacturing and support processes.
The position ensures compliance with applicable standards and regulations (ISO 13485, ISO 11137, ISO 11737, and FDA 21 CFR 820), supports audit readiness, and drives risk-based improvements to maintain validated and controlled processes that ensure product quality and patient safety.
KEY RESPONSIBILITIES- A. Sterilization Validation & Oversight
- 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.
- B. Microbiological Controls & Test Method Validation
- 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 Smart Solve.
- Evaluate and approve laboratory control changes, ensuring continued suitability for intended use.
- C. Environmental & Cleanroom Monitoring
- Own and maintain the environmental monitoring (EM) program for controlled areas and clean rooms used for product assembly and packaging, ensuring compliance with ISO 14644 and ISO 14698.
- Review EM trending data, initiate and lead…
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