Join VitalPath in New Hope as a Quality Engineer II! 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 This person is primarily responsible for providing technical support to ensure Customer requirements are understood and properly implemented. The Quality Engineer II will work cross-functionally contributing to Development and Manufacturing, Engineering, Qualification, and Validation activities. Supports Engineering, Operations, Sales, and Quality by providing effective Non-conformance processing, Supplier control and Outsourced services integrity, Complaint handling, and related CAPA activities. Responsibilities Support engineering, manufacturing, inspection, qualification, and validation of products Develop and implement quality improvement with working knowledge of Quality standards and systems Assures compliance of the Quality Management Systems (QMS), ISO 13485:2016, and customer/regulatory requirements Support Development activities for the transition of Manufacturing Processes and related controlled documentation from prototype control to pre-production control to commercial production control Works with customers and suppliers to resolve quality related issues Support and participate in 3rd party and customer audits, as needed Work cross-functionally on failure investigations, root-cause analysis, and corrective action implementation 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 QMD requirements Develop and implement systems for Quality and Inspection support Support implementation of overall company systems that related to Quality Other duties as assigned