Employer Sponsored Job (Free to apply to)
Quality Engineer - Sarasota, FL (66636)
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 to:
- with our commitment to the best professional development.
- 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.
The primary job responsibility for the Quality Engineer 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.
A 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.
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.
This job function indirectly affects product quality.
Manage 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 quality personnel.
Responsible for ensuring all receiving, in-process and final inspection activities are suitably executed.
Responsible for ensuring quality lab or other similar quality areas are suitably maintained and that all inspection and test equipment is validation / calibrated / in good working order.
Plans and prepares work schedules and assigns employees to specific duties.
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 Practices.
Coordinates and updates the master validation plan or schedule as required.
Performs and supports process validation activities associated with both new and/or changed products and maintains associated supporting documentation.
Performs or supports risk analysis activities including dFMEA and / or pFMEA activities as needed.
Develops test methods, write protocols, perform DOEs, execute testing, and perform MINITAB analysis of results, evaluate process stability and capability, and prepare test reports.
Prepare and update quality plans, as required.
Sets quality assurance testing models for analysis of raw materials, materials in process, and finished products.
Communicates with suppliers regarding quality related activities or results and resolves supplier quality related issues.
Performs quality audits as required and prepares audit reports.
Prepares and submits quality reports as required and trends quality issues.
Ensures all direct reports are suitably trained and that training records are maintained.
Implement, revise, and maintain all relevant quality procedures and work instructions.
Coordinate the management of quality retains.
Manage and coordinate non-conforming process and ensure complete records.
Responsible for leading Material Review Board, coordinating the disposition of nonconforming 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 productivity.
Ensures accurate DHR documentation.
Initiates and participate in corrective and preventive action (CAPA) plans and root cause analyses.
Performs other duties as assigned.
Non-exempt and / or exempt quality personnel.
Facilitating and Conduct Training
Coaching, Counseling, Discipline, Separation
Time and Attendance
Key Required Skills & Experiences
Bachelor’s Degree in Engineering or Science required.
Minimum 3 years 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 Standards/regulations.
Good working knowledge of process validation, including protocol development.
Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate quality risks
Strong process validation knowledge and background
Test method development and documentation.
Experience with ASTM methods.
Strong problem-solving skills and ability to make firm decisions
Organization and analytical skills.
Knowledge of lab equipment, instruments, and calibration procedure.
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.
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.
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