|Title:||Quality Systems Engineer|
|Job Location:||Grafton, WI|
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.
Microbrush International is looking for a dynamic, focused, and engaging leader to join our team as the Quality Systems Engineer at our facility in Grafton, Wisconsin. The Quality Systems Engineer will provide support to the manufacturing process within a team oriented, customer-driven organization. This position will provide quality support to the facility related to corrective actions, process control, statistical analysis, component validation, product measurement and testing, product launch, product certification, and audits.
- Track trends and investigate customer complaints/feedback and work with customer service to resolve identified issues.
- Assist with the planning, implementation, and effectiveness verification of corrective and preventive actions.
- Non-conformances: 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.
- Use quality tools to determine root causes of identified issues.
- Review continuous improvement of quality systems, procedures, & executed records to determine gaps and to identify areas for improvement.
- Assist in the management of the change control system. Review proposed changes and help identify related, impacted processes/procedures/ materials/ etc.
- Identify training requirements, identify gaps, and report on overall compliance. Assist with annual and ad hoc GMP training.
- Generation and maintenance of Device Master Records and Device History Files.
- Generation & maintenance of material specifications: raw materials, components, & finished product.
- Assists with the generation, execution, and review of qualification/validation protocols.
- 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).
- Prepare for and host internal/external audits and regulatory inspections.
- Assist with the oversight and management of the document management program.
- Bachelor of Science Degree in a relevant field
- 7+ years of successful quality systems experience in an FDA-regulated environment, or the equivalent combination of education and experience.
- Experience within a high-volume manufacturing facility strongly preferred
- Excellent verbal and written communication skills
- Analytically assess data to determine trends and root causes
- 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 International/Young Innovations, Inc. is an Equal Opportunity Employer and E-Verify participating employer.