|Title:||Quality Engineer Level I|
|Job Location:||Algonquin, IL|
Young Innovations is a manufacturer and marketer of high quality dental equipment and supplies. With an outstanding reputation for quality, our company has a broad portfolio of market leading products across a variety of categories.
We are seeking a talented, self-led, and energetic Quality Engineer Level I to join our team at our Algonquin, IL location. The Quality Engineer is responsible for leading and supporting key Quality Assurance and Quality Engineering efforts within Young Specialty Business. The Quality Engineer will be tasked with ensuring the design control, operations, and distribution efforts are done in compliance to company’s standards and state and federal regulations.
- Perform or take a lead role in internal/external auditing to ISO 13485 requirements, and ensure proper execution of supporting quality system throughout all facets of the operation.
- Design or specify supporting inspection and testing mechanisms, procedures, and equipment as required.
- Support Commercial, Operations and Regulatory efforts for the design, manufacturing, warehousing, and distribution of medical devices and pharmaceuticals.
- Administer and perform investigations of non-conformances and product deviations, and conduct root cause investigation into NCRs leading to implementation of corrective actions.
- Coordinate document control and record management activities.
- Provide Quality Engineering support for the design and modification of medical devices.
- Ensure relabeling and repackaging activities are conducted in compliance to customer and company quality specifications.
- Administer the UDI and product technical documentation to support Regulatory Affairs activities to register products outside the U.S.
- 5 years of related Quality and Regulatory experience within a manufacturing or distribution environment
- Bachelor’s Degree in Engineering or related field is required.
- Established success in an ISO environment, preferably in the medical field.
- Proficiency in MS Office Suite, and experience with ERP, WMS, and MRP software is required.
- Knowledge of common manufacturing and distribution processes.
- Experience with quality and regulatory programs and requirements are required.
- Lean/Six Sigma knowledge and experience is a preferred.
- Ability to prioritize, plan, perform and communicate activities both in written and verbal form.
- Ability to present analysis and evaluation results in a cohesive, understandable and actionable format to cross-functional teams and decision-makers.
- Ability to learn and adapt to change
- Outstanding Attention-to-detail.
- Excellent communication, analytical, negotiation, and organizational skills.
- A friendly, professional demeanor and ability to excel in a team-oriented environment.
- Desire/ability to work successfully in a small company environment
Young Innovations, Inc. is an Equal Opportunity Employer and E-Verify participating employer