Senior Quality Engineer
Company: Kamdon solutions
Posted on: February 23, 2021
Microbrush International develops, produces, and markets innovative
disposable applicators designed for the placement of controlled
amounts of materials in hard-to-reach areas. Microbrush is a wholly
owned subsidiary of Young Innovations, Inc. Young Innovations is a
manufacturer and marketer of high quality dental equipment. Role
Microbrush is looking for a dynamic, focused, and engaging leader
to join our team as the Senior Quality Engineer at our facility in
Grafton, Wisconsin. The Senior Quality Engineer will provide
support to the manufacturing process within a team oriented,
customer-driven organization. This position will provide quality
support to the facility relating to corrective actions, process
control, statistical analysis, process and test method validation,
and continuous improvement.
- Lead the generation, execution, and review of
qualification/validation protocols and reports.
- Lead the planning, implementation, and effectiveness
verification of corrective and preventive actions.
- Assist production with the investigation of component and
finished good non-conformances.
- Assist supplier management and Quality Control with the
investigation of sourced raw materials, components, and finished
- Monitor and investigate deviations from Quality System
- Review continuous improvement of quality systems, procedures, &
executed records to determine gaps and to identify areas for
- Review proposed technical changes and identify related impact
to processes/procedures/ materials etc.
- Generate and maintain specifications for raw materials,
components, & finished product.
- Perform risk assessments (FMEA, etc.) and initiate action
- Assist the QA Manager with gathering and analyzing data to
determine performance of Quality and Operations (metrics).
- Oversee the site calibration program. Qualifications
- Bachelor of Science Degree in engineering or science.
- ASQ Certified Quality Engineer or Six Sigma Black Belt
- Seven years of quality or engineering experience in an FDA
- Three years process validation experience (IQ, OQ, PQ), test
method validation experience and maintenance of master validation
- Three years experience in sterile packaging and ETO
- Experience within a high-volume manufacturing facility strongly
- Excellent verbal and written communication skills.
- Ability to organize, prioritizes, and perform multiple tasks
with minimal supervision
- A sense of urgency, good attention to detail, and
- Working knowledge of Microsoft Word, Excel, PowerPoint, and
Adobe Acrobat. Microbrush/Young Innovations, Inc. is an Equal
Opportunity Employer and E-Verify participating employer Young
Innovations is an equal opportunity employer and recruits, hires,
trains and promotes persons in all job titles without regard to
race, color, religion, sex, national origin, age, citizenship,
disability or veteran status.
Keywords: Kamdon solutions, Worcester , Senior Quality Engineer, Engineering , Grafton, Massachusetts
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