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Ormco
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Summary: Plans and conducts activities concerned with the quality assurance of industrial processes, materials, and products by performing the following duties.


Essential Duties and Responsibilities: include the following. Other duties may be assigned.

  • Maintains process and software validation plans.  Writes process and or software validation protocols. Facilitates completion of validation activities, performs data analysis, and writes the validation  report. 
  • Performs quality engineering reviews of design documentation for compliance with stated requirements.
  • Is an active and vocal member of product development teams and participates in product design reviews.
  • Applies statistical analyzing of data to evaluate the current process and process changes.
  • Reviews all purchased products or components and provides input to the decision of whether to accept the product and future purchases from the vendor.
  • Documents data obtained during all quality assurance activities, consistent with company policies and procedures.
  • Develops new approaches to solve problems identified during quality engineering activities.
  • Communicates significant issues or developments identified during quality assurance activities and provides recommended process improvements to management.
  • Prepares reports to communicate involvement and results of quality assurance and quality engineering activities.
  • Prepares and presents technical and program information to team members and management.
  • Directs technical and administrative workers engaged in quality assurance activities.
  • Maintains a working knowledge of FDA GMP and ISO 13485 standards.

Required :                                               

  • Bachelor's degree (B. S.) in Engineering from a four-year college or university.
  • 3+ years of process validation experience

Preferred Skills:

  • Masters Degree
  • ASQ certification
  • QE experience within the medical device industry
  • Knowledge of statistical techniques like Gage R&R Studies, Design of Experiments, Failure Mode and Effects Analysis, Statistical Process Control, and Sampling Plans.


Qualifications :

  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with some guidance from fellow senior quality engineers and or supervisor. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Language Skills:                                                         

  • Ability to read and interpret technical documents such as operating and maintenance instructions, engineering drawings, and equipment manuals.  Ability to write routine reports and correspondence.  Ability to speak effectively before groups of customers or employees of the organization.

Mathematical Skills :                                                 

  • Ability to work with mathematical concepts such as probability and statistical inference and fundamentals of plane and solid geometry and trigonometry.  Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Reasoning Ability:                                                     

  • Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Computer Skills:                                                        

  • To perform this job successfully, an individual should have working knowledge of Microsoft Office (Word, Excel, Access, PowerPoint). 
 
Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf.
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About Envista

Envista is a global family of three companies and more than 30 trusted dental brands, united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists’ clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. Envista companies, including KaVo Kerr, Nobel Biocare Systems, and Ormco, partner with dental professionals to help them deliver the best possible patient care.


Envista separated from Danaher as an independent company in 2019. We brought with us the proven Envista Business System (EBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus to meet the end-to-end needs of dental professionals worldwide. Envista is now one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry. For more information, please visit www.envistaco.com.

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