Quality Engineer
Dentsply International - Sarasota, FL

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How does it feel knowing that DENTSPLY International; the premier dental company in six continents with over 10,000 employees around the globe, the world-wide industry leader in innovation and technology is looking for you to join the team! At DENTSPLY International, we do not hire employees, but true business partners who will live the DENTSPLY vision: Always First in dentistry; delivering world-class dental products with world-class precision and technology.

DENTSPLY's broad global product platform helps dental professionals serve patient's oral health care for a lifetime, from preventative services to tooth replacement. Our products range from general dental consumables and laboratory products to products supporting the dental specialty markets of orthodontics, endodontics and implants. With a presence in more than 120 countries, our geographic footprint virtually mirrors the dental market. Please click on the link for additional information on DENTSPLY: www.dentsply.com

Job Summary: The Quality Engineer is responsible for developing test methods, write protocols, perform DOEs - execute testing, and perform MINITAB analysis of results, evaluate process stability and capability, and prepare test reports.

This position requires 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. In addition, responsible for coordinating resolution of lower level issues by leading smaller teams of personnel from all areas of Manufacturing, Engineering, Purchasing, Supply Chain, and Technical Resources.

Essential Duties:
  • Works closely with R&D, Design engineering, contributes in developing quality specifications for new products.
  • Updates dFMEA and pFMEA within process development, ensures compliance with GMPs.
  • Keeps track of new tooling prototypes, identifies and assumes responsibilities for storage of the engineering samples. Performs essential measurements, testing, analysis, keeps records and communicates to team about findings.
  • Performs light mechanical design for quality gages and fixturing, reliability analysis, problem solving and continuous improvement activities.
  • Communicates with suppliers about inspection and test results of prototypes. Maintains revisions of process specifications.
  • Analyzes Non-conformance event and complaint data analysis, investigates root causes, proposes improvements, and maintains NCE / CAPA documentation.
  • 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.
  • Initiates corrective and preventive action (CAPA) plans with root cause analyses.
Education and Experience:
  • Bachelors of Science in Mechanical Engineering
  • Six Sigma Green Belt preferred
  • Minimum 3 years full time experience in a Lean Six Sigma Quality engineering role
  • Two (2) years of practical medical device manufacturing experience is preferred.
Qualifications:
  • Working knowledge of FDA, cGMP and ISO Standards/regulations.
  • Able to read and interpret mechanical drawings
  • Experience with ASTM methods
  • Knowledge of Six Sigma methodology, SPC techniques and MINITAB data analysis
  • Organization and analytical skills
  • 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.
DENTSPLY International is an Equal Opportunity Employer M/F/D/V

Dentsply International - 21 months ago - save job - copy to clipboard - block
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