Quality Engineer, Microbiological Specialist

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.

SCOPE

The 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

1. 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 SmartSolve.
   • 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 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.
   
   D. Compliance & Continuous Improvement
   • 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.
   
   E. Cross-Functional and Global Collaboration
   • 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.

F. Equipment and process Validation

• 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.

EDUCATION:

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.

CERTIFICATIONS/LICENSING

• Six Sigma is preferred
• American Society of Quality – Engineer preferred
• Professional Engineering Certificate preferred

Years and Type of Experience:

3–5+ years of experience in sterilization validation and microbiological quality systems in the medical device or pharmaceutical industry.

Key Required Skills, Knowledge and Capabilities:

• 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.
• Hands-on experience with SmartSolve, TrackWise, or equivalent electronic QMS preferred.
• 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 inquires 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.