Quality Engineer - Johnson City, United States - Dentsply Sirona

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. The company's shares are listed in the United States on NASDAQ under the symbol XRAY.

This position is located in Johnson City which is the largest city in the Tri-Cities area, located in the north eastern region of Tennessee at the foothills of the Appalachian Mountains.

The city is a growing metropolis with invigorating music, enchanting culture, and exhilarating mountain adventures.

Its natural beauty and fresh mountain air combined with amenities that are often only available in larger cities make Johnson City the perfect location.

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.


Position Summary:

This position is responsible for maintaining the quality system and for developing innovative solutions to quality related problems identified through quality system data collection and analysis.

Assures compliance to quality control guidelines and procedures to ensure that raw materials and finished goods comply with engineering and product specifications.

Assists in the design and implementation of policies and procedures for testing and evaluating the precision and accuracy of products and/or equipment.

Assists in Root Cause Analysis. Ensures projects are completed on time and within budget. Supports product development team regarding projects, tasks, and operations. Supports Global Business Unit reporting and initiatives. Sterilization processing and Clean Room experience helpful.


Key Responsibilities
:

• Supports company goals and objectives, policies, and procedures in compliance with quality systems, FDA regulations and all other external regulatory requirements for which product is distributed
• Assesses, provides recommendations, and leads implementation of systems, processes and equipment for improvement and compliance to cGMP and ISO 13485:2016 within the R&D, Operations, Quality and Regulatory processes to ensure safe and effective products are produced. Provides written reports and supporting documentation for recommendations
• Provides quality engineering support to manufacturing and product development groups for assigned Value Stream and other operation teams.
• Develops and implements quality control process sampling systems, procedures, and statistical techniques.
• Performs statistical analysis of data and writes technical reports.
• Ensures accurate project schedules are maintained and communicated to both internal and external management.
• Supports other quality functions which may include QA/QC sampling plans, supplier development, and quality training initiatives.
• Supports internal/external/corporate audits
• Develops/Maintains a site Quality Culture initiative
• Supports customer feedback investigations, to include root cause investigation and resolution.
• Presents data analysis and trend information to management and other groups as required.
• Establishes and maintains Procedures and policies in support of the quality/manufacturing interface.
• Supports the CAPA process, as needed, collaborating with owners to ensure effective root cause analysis and the development of innovative, long-term solutions.
• Ensures MRB processes are followed, Nonconformances are processed according to procedure, and provide technical input and analysis to MRB team in addition to identifying and developing solutions to recurring issues.
• Evaluates data and identify trends related to Non-Conformance/Quality Holds and other data, as needed/requested, in order to collaboratively develop innovative solutions and communicate to management when appropriate.
• Leads problem solving efforts, in conjunction with manufacturing, collaboratively, to identify and resolve recurring and new quality issues to ensure production of safe and effective medical devices.
• Works collaboratively with Operations and R&D project teams to develop and implement appropriate risk management, qualification, verification, and validation plans.
• Establishes programs to evaluate precision and accuracy of production equipment for testing, measurement, and analytical equipment and facilities.
• Prepares and reviews qualification and validation test plans and reports for assigned projects, including, if required, reliability assessments.
• Performs machine and process capability and performance studies (verification/validation/SPC, etc.); recommends and upon approval, implements changes and upgrades to quality systems, procedures, or processes to improve product quality.
• Supports Clean Room Activities
• Depending on the needs of the company, the employee may be entrusted with and asked to perform other tasks related to his/her competence.

Education
:

• Bachelor's Degree from an accredited college or university or equivalent combination of experience and education.

Certifications/Licensing
:

• Six Sigma is preferred
• American Society of Quality – Engineer preferred.
• Professional Engineering Certificate preferred.

Years and Type of Experience
:

• 3 years minimum experience in engineering or related field preferred.

Key Required Skills, Knowledge, and Capabilities
:

• Understanding of Good Manufacturing Practices, Quality Systems, Regulatory requirements, validation principles and manufacturing methods in Medical Device regulated environment.
• Understanding of inputs, outputs, raw materials, waste, quality control, costs, and techniques for maximizing the manufacture and distribution of goods.
• Creative problem solving, flexibility and sound negotiation skills.
• Strong project management skills as well as an ability to multi-task.
• Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry helpful.
• Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
• Ability to analyze, estimate and evaluate data.
• Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.
• Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.) in its most difficult phases.
• Ability to deal with a variety of abstract and concrete variables.
• Ability to read, analyze and interpret common scientific and technical journals, financial reports, and legal documents.
• Ability to write reports, business correspondence and procedure manuals.
• Ability to respond internally to common inquires or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to top management, groups and /or boards of directors.

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 ) . 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