Company Overview
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 Overview
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.

Responsibilities

• 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 goods.
• Monitor and investigate deviations from Quality System processes.
• Review continuous improvement of quality systems, procedures, & executed records to determine gaps and to identify areas for improvement.
• 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 plans.
• 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 Certification desired.
• Seven years of quality or engineering experience in an FDA regulated environment.
• Three years process validation experience (IQ, OQ, PQ), test method validation experience and maintenance of master validation plans.
• Three years experience in sterile packaging and ETO sterilization desired.
• Experience within a high-volume manufacturing facility strongly preferred
• 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 follow-thru.
• Working knowledge of Microsoft Word, Excel, PowerPoint, and Adobe Acrobat.

Microbrush/Young Innovations, Inc. is an Equal Opportunity Employer and E-Verify participating employer