Dentsply Sirona · 13 hours ago
Quality Engineer I
Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, dedicated to improving dental care. The Quality Engineer I will ensure compliance with Quality Assurance and manufacturing processes while supporting overall quality initiatives, including conducting investigations and maintaining calibration systems.
DentalEducationHealth CareManufacturingMedical Device
Responsibilities
Overseeing the day-to-day functions of the Sarasota site Calibration system
Conducting Complaint investigations
Maintaining and Programing electronic measurement equipment
Development and execution of test methods, protocols, and DOEs and performing MINITAB analysis of results
Ensuring conformance of all phases of a products lifecycle in a world-wide regulated medical device environment
Implementing/improving statistical process control techniques
NC/CAPA Complaint Investigation and MRB participation, as applicable
Acts as an internal champion for quality initiatives aimed at improving business systems and compliance; may be the primary representative of Quality group on projects
Works closely with Manufacturing Engineering
Active team member during risk assessment activities and updates associated pFMEAs as required
Supports the development of test methods, writes protocols, performs DOEs, executes testing, and performs MINITAB analysis of results, evaluates process stability and capability, and prepares test reports
Performs essential measurements, testing, analysis, and keeps records using Good Documentation Practices and communicates to team about findings
Supports process validation activities associated with both new and/or changed products
Supports reliability analysis, problem solving and continuous improvement activities
Maintains compliance of the Sarasota site Calibration system and reports on calibration metrics
Site Administrator to ensure compliance and control of all measuring and test equipment in accordance with calibration and verification process
Ensures all new test equipment is calibrated and entered into calibration tracking system
Acts as subject matter expert and programmer for the Visual Measurement Systems utilized within the facility
Independently investigates complaints in accordance with applicable medical device regulations and internal Quality Management System (QMS) processes/procedures, while ensuring investigations are completed in accordance with the defined timeframes
Maintains compliance of the Sarasota site Non-conformance system, ensuring all product non-conformance documentation is complete, timely and in accordance with established procedures, regulations and requirements
Contributes in preparing and updating quality plans, as required
Assists in preparation and updates of manufacturing procedure documentation, and quality procedure documentation
Active CAPA owner, conducting root cause investigations and providing appropriate abatement solutions to prevent reoccurrence
Maintains NC / CAPA documentation in a timely manner
Participates in process improvement activities within the business to drive consumer satisfaction levels and business productivity
Supports the implementation of new/updated manufacturing processes
Drives a culture of continuous improvement and identifies actions to eliminate process variation
Participates in assessment teams in applying quantitative tools to identify the current state from which improvement opportunities exist
Communicates project progress, capture cost savings, consumer satisfaction, or other appropriate business productivity metrics to direct supervisor
Documents data obtained during all quality activities using good documentation practices
Communicates significant issues or developments identified during quality activities and provides recommended process improvements to direct supervisor
Identifies and proposes continuous improvement opportunities to direct supervisor
Initiates corrective and preventive action (CAPA) plans with root cause analyses as needed
May participate in external customer, quality systems and regulatory agency audits/inspections as required
May participate in internal auditing program as qualified internal auditor
Other duties as approved by manager
Qualification
Required
Bachelor Degree in Science, Engineering or similar field, or equivalent combination of education and experience is required
Minimum 1 year full time experience in a Quality Engineering role is preferred, but advanced degrees and/or internship experience will also be considered
General knowledge of FDA, cGMP and ISO Standards/regulations
General knowledge of upstream process development and validations, including protocol development
Able to read and interpret mechanical drawings
Test method development and documentation
General knowledge of Six Sigma methodology, SPC techniques and MINITAB data analysis
Proficient in Microsoft Office software including Outlook, Word, Excel, Power Point and Visio
Organization and analytical skills
General knowledge vision measurement equipment, and calibration procedures
Ability to work in a cross-functional team setting
Detailed oriented, high energy, self-starter, who exercises sound judgment and deliver against company business goals and objectives
Excellent communication, and presentation skills, both orally and written
Results oriented change agent
Ability to read, write and communicate in English
Preferred
Minimum 1 year full time experience in a Quality Engineering role is preferred, but advanced degrees and/or internship experience will also be considered
One (1) year of practical medical device manufacturing experience is preferred
Ability to speak Spanish a plus
Company
Dentsply Sirona
Dentsply Sirona is a manufacturer of dental products and technologies.
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
Recent News
2026-01-14
2026-01-14
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