Quality Engineer II - Sarasota, FL

Company: Dentsply Sirona
Location: Sarasota
Posted on: August 4, 2022

Job Description:

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

Develop 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 Summary

The 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 Responsibilities

• Interacts with non-exempt quality personnel responsible for routine inspection and testing activities. May mentor Jr. level Quality Engineers.
• 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 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, 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 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.
• 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 complete records.
• 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 productivity.
• 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 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 delivers 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.
        
        If you need assistance with completing the online application due to a disability, please send an accommodation request to
        

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