Sr. Quality Engineer - Milford, DE

Dentsply Sirona - Milford, DE (30+ days ago)3.8


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. As The Dental Solutions CompanyTM, Dentsply Sirona’s products provide innovative, high-quality and effective solutions to advance patient care and deliver better, safer and faster dentistry. Dentsply Sirona’s global headquarters is located in York, Pennsylvania, and the international headquarters is based in Salzburg, Austria. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY. This position is location in the heart of Southern Delaware; located just 25 miles north of Rehoboth Beach and only 20 miles south of the state’s capital, Dover. Also, we are centrally located east and south of Baltimore, Philadelphia and Washington DC. Whether standing at a scenic point along the downtown River walk, or spending the day at one of Delaware’s beautiful beaches, know that underneath the calm tranquility is the energy of a community on the move!

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.

Terrific opportunity to be part of our Quality team.

Position Summary:

The Sr. Quality Engineer will support various Quality Engineering efforts, specifically related to the overall Quality Planning activities, which may include: Risk Assessment support (FMEA), specification development for Raw Materials/ Components, Intermediated, Bulk, Finished product.

Key Responsibilities:
  • Provides technical expertise in Quality Planning activities and in the introduction of new product through FMEA and process capability analyses as well as designing and implementing design verification/validation plan, protocols, and reports.
  • Guides and directs engineering in the development of robust and efficient process and design validations with core teams, as well as perform testing methods.
  • Works closely with suppliers and other sites to establish and align appropriate specification and test methods.
  • Material Review Board member, providing oversite and timely disposition of site nonconformance.
  • Leads Corrective and Preventive Action (CAPA) Teams and uses Root Causes Analysis tools to document CAPA activities.
  • Expert in applied statistical methodologies (MSA, DOE, Sampling Plans, SPC, etc.) to support site validations and inspection requirements. Trains employees in the concepts of probability and statistics.
  • Develops, implements, and controls quality programs for the conformance of product systems, including such information as the number of units to be inspected/tested, the frequency to test, test methods and yield determination.
  • As required, acts as divisional Material Review Board to ensure nonconforming materials include compliant documentation and disposition.
  • Leads process and product audits as well as internal Quality System audits.
  • Identifies areas for improvement and leads the effort for continuous process improvement.
  • Acts as liaison between departments and make independent decisions to ensure adherence to quality procedures.
  • Establishes, collects and analyzes data for metrics reporting for results of activities to identify areas of potential improvement.
  • Leads the development of presentation of data for the Annual Product Review.
  • Executes verification and/or validation protocols for products and/or processes.
  • Works with all business units to improve material flow, ensure process quality, reduce work in process, and achieve required capacity/cycle time requirements to meet or exceed customer requirements.
  • Leads problem/root-cause investigations for acute defect problems.
  • Supports QA Audit systems by serving as internal audit leader.
  • Work with procurement and supplies to ensure Milford quality requirements are met.
  • Other duties to support team and business goals.

Education an
d Certifications: A Bachelors degree in a Technical Science (Engineering, Chemistry) is required. An advanced technical degree preferred. An equivalent combination of education and experience will be considered. ASQ Certified Quality Engineer or 6 Sigma Black Belt preferred. Years andType of Experience: A minimum of six (6) to ten (10) years’ work experience in Engineering or Manufacturing environment. Five (5) plus years experience in the medical device industry is preferred. Strong working knowledge of applied statistical techniques Experience leading teams using formal problem-solving skills Experience with process validations Key Required Skills, Knowledge and Capabilities:

Technical Skills:

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, diagram, or schedule form. Ability to define problems collects data, establish facts, and draw valid conclusions. Able to formulate an approach and plan projects.

Mathematical Skills:

Ability to understand mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentage, ratios, metric measurement and proportions to practical situations.

Leadership Skills:

Lead, manage, and implement initiatives to support the QA/RA Department goals and objectives. Proactively communicate negative and positive trends to the organization in support of on-going goals and metrics.

Data Analysis:

Analyze and interpret data to meet tight deadlines. Make recommendations based on a review of numerical data, written reports, and trends. Strong problem-solving skills; able to come up with alternative solutions for management consideration based on data analysis.

Communication, Presentation and Relationship Building Skills:

Deliver presentations throughout all levels of the organization to drive for results. Build relationships throughout all levels of the organization to meet tight deadlines and metrics. Effectively communicate through out all levels of an organization. This includes written, verbal communications and presentations. Strong technical oral and written communication skills.

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.