Quality Engineer, York, PA
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 located in York, Pennsylvania. Offering the cultural attractions of a big city and the down-home charm of a small town, York, PA is an extraordinary place to live, work and play. York is located in south-central Pennsylvania and is within 25 miles of Gettysburg and Lancaster, 45 miles of Baltimore and Hershey, and 100 miles of Washington, DC and Philadelphia. Engrained with a rich history and heritage and becoming one of the fastest growing cities in Pennsylvania, York is a place where the past and the present comfortably coexist.
Under general supervision, participates in the various Quality Engineering efforts which include: benchmarking and process improvement implementation, corrective and preventive actions, process and design validation, key supplier quality initiatives, test method and gage design and control, and root-cause analysis of defects from manufacturing and customer returns. Performs related work and other duties as required.
- Develops, implements, and monitors various reporting systems concerning product returns, performance and quality to assist top management in problem resolution and product decision making.
- Identifies quality issues, develops, implements and performs trend analysis on corrective and preventive actions through coordinated efforts with R&D and Manufacturing as required.
- Provides technical expertise 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.
- Leads Corrective and Preventive Action (CAPA) Teams and uses Root Causes Analysis tools to document CAPA activities
- 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.
- Controls non-conforming product and is responsible for its disposition and/or release
- Assists in the introduction of new products through FMEA and process capability analyses as well as designing and implementing design verification/validation protocols.
- Continually improves techniques for functional and extended performance testing.
- Coordinates problem / root-cause investigations for acute defect problems.
- Develops, implements and monitors methods and procedures to continuously monitor customer satisfaction.
- Develops quality systems for material conformance according to AQL and SPC controls.
- Leads process and product audits as well as internal Quality System audits.
- Identifies areas for improvement and leads the effort for continuous process improvement.
- Executes verification and/or validation protocols for products and/or processes
- Assists with calibration and control of gages.
- Provide leadership and guidance to the division in the attaining of its quality goals.
- Develop a culture within the division of managing and making decisions based on the understanding of the nature of variation.
- Acts as liaison between departments and makes independent decisions to ensure adherence to quality procedures.
- Establishes, collects and analyzes data for metrics reporting for results of activities for potentially adverse trends and SPC trend analysis.
- Develops and maintains Statistical Process Control Policies for facility. Implements Statistical Process Controls (SPC) and support from practical implementation to advanced techniques, and analysis.
- Prepares status reports for management and presents status to senior management as required.
- Leads Project V&V Phase and support other phases of GIP system
- 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.
- Works with key suppliers to identify critical requirements to ensure quality of supplied parts/components
- May be responsible for reviewing, documenting, logging, maintaining and/or initiating the investigation for potentially serious complaints.
- Identifies employee-training needs to support quality programs and develops and delivers these training programs.
- Leads problem/root-cause investigations for acute defect problems
- Supports New Product Development teams, based on market needs, to input into the development process, document and implement regulatory strategies, including registration requirements, needed to help facilitate timely launch of new products.
- May manage personnel within group with responsibilities to include staffing, performance management, development and coaching, training, and application of policies, programs, and procedures. Assures that a positive employee relations environment is maintained through effective communication.
- Interact with various cross-functional teams.
- Interacts with Marketing Product Managers
- Prepares, maintain and submits periodic reports, as required.
- Maintains clean and safe working environment in line with company policies.
- Wears required personal protective equipment (PPE) for work being performed.
- Serves as a contributing member/leader on Quality Improvement Teams.
- May serve as backup to the Division Complaint Officer, including the reviewing, documenting, logging, maintaining and/or initiating the investigation for potentially serious complaints as well as reporting, evaluation, and classification of customer complaints. Included in this function is the development of various reports to present to the Product Surveillance Committee (PSC).
Training and Experience
- Bachelor's Degree in Mechanical or Electrical Engineering or related engineering field.
- Three (3) years of experience in a technical or quality role, preferably in a medical device ISO 13485 certified facility.
- CQE Certification or equivalent experience preferred.
- At least 2 years of demonstrated project management experience.
Knowledge, Abilities and Skills
- Strong statistical analysis skills including knowledge of Design Of Experiments (DOE), SPC, and Taguchi methods
- Expert statistical understanding of capability studies and sampling plans.
- In depth ability to analyze data with various statistical programs and prepare reports.
- Proficiency with Lotus Notes, MS Office, including Excel, Word, and Powerpoint.
- Good communication skills, both orally and written, at all levels of an organization.
- Good understanding of cGMP, ISO 13485 and FDA Quality Systems, work experience in a FDA regulated company preferred.
- Demonstrated ability to solve practical problems and make logical decisions.
- General knowledge of mechanical and electronic test equipment.
- Strong organizational skills and attention to detail.
- Able to read and understand technical information, and company SOP's.
- A wide degree of creativity and initiative is expected.
- Ability to work with a diverse collaborative team environment.
- Ability to apply lean six sigma problem solving methodology is strongly preferred.
- Strong leadership ability.
- Frequently required to walk, kneel, stand, sit, push, pull, stoop, and bend over.
- Occasionally required to lift and carry up to 30 pounds.
- Have normal eye/hand motor coordination and the ability to grasp small objects.
- Possess a normal extended reach.
- Have the ability to determine colors and possess near acuity.
- Able to use a personal computer and other office equipment, unassisted.
Lab environment as well as manufacturing plant environment with some abnormal variations in temperature, unavoidable fumes, noise, dust, and atmospheric conditions.
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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Sat, 25 Mar 2017 20:38:26 PDT