|Job Location:||Missoula, MT|
Young Innovations is a manufacturer and marketer of high quality dental equipment and supplies with sales in excess of $140 million. With an outstanding reputation for quality, our company has a broad portfolio of market leading products across a variety of categories.
The Quality and Regulatory Engineer will be tasked with insuring Quality and Regulatory standards are met or exceeded in all facets of the operation, and will also take a lead role in error cause removal and process improvement; and perform related duties as required.
- 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. Additionally, design or specify supporting inspection and testing mechanisms, procedures, and equipment as required.
- Ensure outstanding vendor performance via completion of vendor qualification, monitoring and measuring of supplier performance, and driving any appropriate action, including issuing and follow-up of CAPAs, and periodic completion of vendor review board.
- Complete all necessary regulatory work, including certification and validation necessary to pass governing regulatory agency standards, obtain certification marks for products, etc.
- Perform investigations of non-conformances and product deviations, and conduct root cause investigation into NCRs leading to implementation of corrective actions.
- Manage Document and Record Keeping functions, including creation and review of work instructions and all other documentation for assembly, distribution, and all associated tasks, DMRs, and product Tech Files. Manage change control, and DCRs as necessary.
- Utilizing Lean methodology and/or other techniques, take a lead role in identifying process improvement opportunities, prove ROI, and execute proposed change and all necessary change documentation.
- Perform in-house calibration or administer outside calibration of measuring devices and equipment.
- Support Engineering and Product teams in any development activity.
- The Quality and Regulatory Engineer will also be a key contributor to the Operations leadership team.
Training and Experience
- Bachelor’s Degree in Engineering or related field is required.
- Five years of related Quality and Regulatory experience within a manufacturing or distribution environment
- Established success in an ISO environment, preferably in the medical field.
Knowledge, Abilities and Skills
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 is 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