Envista Holdings Corporation Quality Engineer in Romulus, Michigan
KaVo Kerr is a cohesive organization comprised of two global leaders, united to provide dental excellence and serve as a single premier partner for the dental community. KaVo Kerr operates with a common vision inspiring and helping our customers, their patients and our own associates realize their potential. KaVo Kerr offers solutions for endodontics, restoratives, treatment units, infection prevention, imaging, rotary and instruments.
describe role accountabilities, for example in one or more of the following areas
Implements process, software and test method validation policy and procedures. Writes protocols, facilitates completion of validation protocol procedures, performs data analysis, and writes reports.
inter-company transfers of processes or in-sourcing activities
updates or changes to processes, software and test methods
introduction of new processes, new software, new test methods and new products
Maintains Process and Software Validation Master Plans.
Participates in product development teams and in design reviews.
Conducts root cause and corrective action investigations for quality failures, including those occurring in supplier and internal processes.
Improves quality system by evaluation and improvement to inspection and test methods, sampling plans, and process control plans.
Completion of the above duties and responsibilities will include the use of Gauge R&R Studies, Design of Experiments, Failure Mode and Effects Analysis, Statistical Process Control, Capability Studies, the determination of Operating Characteristics for Sampling Plans, and general statistical analysis of data.
Prepare and conduct training sessions and presentations as required to complete the above duties and responsibilities.
Plans and conducts the analysis, inspection, design, test, and/or integration to assure the quality of assigned product or component
Performs quality engineering reviews of design documentation for compliance with stated requirements, including vendor quality manuals and company quality records.
Applies statistical process control (SPC) methods for analyzing 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.
Maintains a working knowledge of government and industry quality assurance codes and standards
Support, and when appropriate lead, CAPA’s creation and resolution
Other duties as assigned
4+ years of Quality Engineering exp
BS or BA Degree in Business, Engineering or Project Management required
Master’s Degree preferred
Quality testing and experience in GMP quality processes in Medical Device production
Measuring systems and analytics
Production systems, ERP knowledge a plus
Technical drawing reading
Experience in lean manufacturing of Medical Devices
Ability to accurately assess quality measurements and manufacturing operational metrics and situations and effectively address root cause and counter measure implementation
Familiarity with various manufacturing process technologies
Proficiency in project leadership and management
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
Ability to write routine reports and correspondence.
Ability to speak effectively before groups of customers or employees of organization.
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
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
To perform this job successfully, an individual should have knowledge of Spreadsheet software and Word Processing software
QMS expertise - Proven process improvement and change management skills - Ability to apply lean manufacturing concepts and develop and install best practices across diverse business environments
Ability to work and influence all levels of the organization from Senior Leaders, Functional Leaders to project managers and practitioners in all functional areas
Ability to work with cross-functional teams globally
Independence and good judgment, positive attitude, and an innovative spirit
Manufacturing quality systems
GMP general standards
ISO standards relating to Medical Device
Proficiency in continuous improvement
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.
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.
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 (DBS) 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 .
Envista Holdings Corporation
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