Quality Engineer II - Sarasota, FL
Company: Dentsply Sirona
Posted on: August 1, 2022
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, USA. The company's shares are listed in the United
States on NASDAQ under the symbol XRAY. 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
ToDevelop 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.
Job SummaryThe primary job responsibility of a Quality Engineer II
(QE II) is to be a proven problem solver with the ability to use
data to identify, analyze and solve complex problems and eliminate
the overall Cost of Poor Quality related to the facilities,
processes, and products.The QE II typically has people management
responsibilities and leads the resolution of quality-related issues
by leading teams of personnel from all areas including
Manufacturing, Engineering, Purchasing, Supply Chain, and Technical
Resources.Additionally, the QEII will be responsible for, but not
limited to overseeing the day-to-day functions and mitigation of
concerns for production; mentoring and providing guidance to the
SBU's quality staff; driving change and elimination of waste within
the organization, and 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.Key
- Oversee non-exempt quality personnel responsible for routine
inspection and testing activities. This position may also be
responsible for managing exempt Quality Engineers I or other
- Ensures all receiving, in-process and final inspection
activities are suitably executed.
- Ensures quality lab or other similar quality areas are suitably
maintained and that all inspection and test equipment is
validated/calibrated / in good working order.
- Plans and prepares work schedules and assigns employees to
- Works closely with Operations, R&D, and Engineering to
ensure that all quality initiatives are successfully executed and
that activities are performed in accordance with Good Manufacturing
- Coordinates and updates the master validation plan or schedule
- Performs and supports process validation activities associated
with both new and/or changed products and maintains associated
- Performs or supports risk analysis activities including dFMEA
and/or pFMEA activities as needed.
- Develops test methods, writes protocols, performs DOEs,
executes testing, performs MINITAB analysis of results, evaluates
process stability and capability, and prepares test reports.
- Prepares and updates quality plans, as required.
- Sets quality assurance testing models for the analysis of raw
materials, materials in process, and finished products.
- Communicates with suppliers regarding quality-related
activities or results and resolves supplier quality-related
- Performs quality audits as required and prepares audit
- Prepares and submits quality reports as required and trends
- Ensures all direct reports are suitably trained and that
training records are maintained.
- Implements, revises, and maintains all relevant quality
procedures and work instructions.
- Coordinates the management of quality retains.
- Manage and coordinate the non-conforming processes and ensure
- Responsible for leading Material Review Board, coordinating the
disposition of non-conforming products, and ensuring the storage of
nonconforming material product is suitably managed.
- Participates in process improvement activities within the
business to drive consumer satisfaction levels and business
- Ensures accurate DHR documentation.
- Initiates and participates in corrective and preventive action
(CAPA) plans and root cause analyses.
- Performs other duties as assigned. Supervisory Responsibilities
- Non-exempt and/or exempt quality personnel.
- Facilitating and Conduct Training
- Coaching, Counseling, Discipline, Separation
- Employee Development
- Performance Management
- Time and Attendance Educational Qualifications
- Bachelor's Degree in Engineering or Science required. Required
Knowledge, Skills, And Abilities
- Minimum 3 years of full-time experience in a quality
engineering or similar role.
- Demonstrated knowledge of Six Sigma methodology, SPC
techniques, and MINITAB data analysis.
- Three (3) years of practical medical device manufacturing
experience is preferred.
- Working knowledge of FDA, cGMP, and ISO
- Good working knowledge of process validation, including
- Ability to assess project risks, and where appropriate,
recommend contingency plans and strategies to mitigate quality
- Strong process validation knowledge and background
- Test method development and documentation.
- Experience with ASTM methods.
- Strong problem-solving skills and ability to make firm
- Organization and analytical skills.
- Knowledge of lab equipment, instruments, and calibration
- Ability to work in a cross-functional team setting.
- Detailed oriented, high energy, self-starter, who exercises
sound judgment and delivers against company business goals and
- Excellent communication, and presentation skills, both orally
- Results-oriented change agent.
Dentsply Sirona is an Equal Opportunity/ Affirmative Action
employer. All qualified applicants will receive consideration for
employment without regard to race, color, religion, sex, national
origin, age, sexual orientation, disability, or protected Veteran
status. We appreciate your interest in Dentsply Sirona.If you need
assistance with completing the online application due to a
disability, please send an accommodation request to
Keywords: Dentsply Sirona, Sarasota , Quality Engineer II - Sarasota, FL, Engineering , Sarasota, Florida
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