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. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY. This position is located in Waltham, MA, a city along the Charles River in Middlesex County, Massachusetts with rich cultural history that can be explored at various world class monuments, museums and art galleries. The city is a hub for scientific research and higher education with several renowned universities. Waltham also includes numerous high-tech companies and is located in the Boston Route 128 High Technology Corridor only nine miles from Boston which makes this an attractive location to live, work and play.
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.
SCOPE:
The primary job responsibility for the Quality Engineer I is for ensuring the compliance of the manufacturing process(es) and directly supporting overall quality initiatives within the organization. This is included but not limited to: Development and execution of developing test methods, write protocols, perform DOEs - execute testing, and performing MINITAB analysis of results, evaluate design stability and capability, and preparing test reports. Ensuring conformance of all phases of a products lifecycle in an FDA and ISO regulated medical device environment. Implementing/improving statistical process control techniques. NC/CAPA/Complaint Investigation and MRB participation, or management. Risk Management (dFMEA/pFMEA) active team member. This role will promote customer advocacy (both internal and external) using a verity of training and motivational tools while communicating throughout all levels of the business. Communications must include the linkage between projects and desired business results, and reinforce working with manufacturing partners to eliminate process variation key to business improvement and profitability. In addition, they are responsible for coordinating resolution of lower level issues by leading teams from all areas of Manufacturing, Engineering, Purchasing, Supply Chain, and Technical Resources. 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:
Works closely with senior QA Engineers, R&D, Design Engineering, and contributes in developing quality specifications for new products. Active team member during risk assessment activities and updates associated dFMEAs and pFMEAs as required. Develops test methods, write protocols, perform DOEs, execute testing, and perform MINITAB analysis of results, evaluate process stability and capability, and prepare test reports. Assists with the development of new tooling prototypes, identifies and assumes responsibilities for storage of the engineering samples. 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, and maintains all associated supporting documentation for engineering protocols and reports. Assists with mechanical design for quality gages and fixturing. Supports reliability analysis, problem solving and continuous improvement activities. Contributes in preparing and updating quality plans, as required. Assists in preparation and updates of manufacturing procedure documentation, and quality procedure documentation. Maintains revisions of process specifications as required. Assists in the analyses of Non-conforming product/processes and complaint data analysis. Assists in root cause investigations, and provides input to appropriate abatement activities. Maintains NCE / 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 senior QA engineers and/or direct supervisor. Identifies and proposes continuous improvement opportunities to senior QA engineers. Initiates corrective and preventive action (CAPA) plans with root cause analyses as needed. Performs other duties as needed. TYPICAL BACKGROUND:
Educational Qualifications:
Bachelor Degree in Science, Engineering or similar Required Knowledge, Skills, and Abilities:
Minimum 2 years full time experience in a Quality engineering role One (1) year of practical medical device manufacturing experience is preferred. General knowledge of FDA, cGMP and ISO Standards/regulations. Good working knowledge of upstream process development and validation experience, including protocol development. Able to read and interpret mechanical drawings Test method development and documentation General knowledge with ASTM methods General knowledge of Six Sigma methodology, SPC techniques and MINITAB data analysis Microsoft windows applications: power point and Visio Organization and analytical skills General 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 Ability to read, write and communicate in English. Ability to speak Spanish a plus 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 careers@dentsplysirona.com. Please be sure to include “Accommodation Request” in the subject.
For California Residents:
We may collect the following categories of personal information in connection with the submission of your resume or application materials to us for employment, and if hired, your employment with us: identifiers (e.g., name, address, email address, birthdate); personal records (e.g., telephone number, signature, education information, criminal background information, passport number and visa information); consumer characteristics (e.g., sex, marital status, veteran status, race, disability, sexual orientation); professional or employment information (e.g., resume, cover letter, employment history, background check forms, references, certifications, transcripts and languages spoken); and inferences from personal information collected (e.g., a profile reflecting abilities and aptitudes).
The above categories of personal information are collected for the following business purposes: performing recruitment and hiring services; processing interactions and transactions (e.g., to comply with federal and state laws requiring us to maintain certain records, managing the workforce); and security (e.g., detecting security incidents, protecting against fraudulent or illegal activity).
For additional details and questions, contact us at careers@dentsplysirona.com
