Join VitalPath in Maplewood as a Quality Engineer! About VitalPath VitalPath is a trusted partner in the catheter design and manufacturing of custom medical devices that save lives and restore patient health and vital function. We re excited about this important work and bring vital energy to our customer partnerships. In our growing organization it s important that we continue to offer a small-company, family-oriented environment with competitive pay and benefits. If you want to make a difference in people s lives and be a part of a friendly, fun place to work with people that value diversity, come join our team! About the Position The Quality Engineer will be part of the Quality team which assures quality practices and works with customers on their quality needs. Responsibilities Support manufacturing, inspection, qualification, and validation of products Develop and implement quality improvement with working knowledge of Quality standards and systems Enforces Quality Management system (QMS), ISO 13485:2016, and customer/regulatory requirements Works with customers and suppliers to resolve quality related issues Perform internal quality audits and participate in registrar and customer audits, as needed Conduct failure investigations, root-cause analysis, and corrective action implementation Work cross functionally with other in-hours departments & contract manufacturers Develop, approve, review, and update-controlled documents such as Procedures, Manufacturing Procedures, Work Instructions, Forms, etc Train personnel, as needed, on new or updated QMS documents Review and approve customer and internal drawings and specifications Ensure that records are established, accurate and maintained per QMS requirements