Supplier Quality Engineer II

Quality Engineer Develop, communicate, and manage a strategy/plan for addressing finished goods CMs/Suppliers capability deficiencies, etc. Ensure proper approval and documentation practices are followed. Define and manage the process for growing effective "partnerships" with preferred CMS. Develops and prioritizes an auditing schedule. Assist in establishing supplier quality agreements. Delivers strategy on non-conformance management including but not limited to Supplier Change Requests (SCR), Supplier Corrective Actions (SCAR), and complaint investigations. Demonstrate knowledge of domestic and international requirements and standards. Support internal, corporate, notified body, FDA, and other audits. Collaborates with contract manufacturers to evaluate supplier scorecards and address low-performing suppliers with appropriate corrective action plans. Provides Pre-Market Quality Engineering support to New Product Development (NPD). Drives Quality in collaboration with cross-functional stakeholders and contract manufacturers where necessary. Evaluate CMs and develop reports on CM quality performance for company management, recommend and implement the continuous improvement of CM quality systems. Responsible for ensuring that effective up-to-date CM Quality Assurance documentation, procedures, and specifications are maintained. This position requires a master's degree in Industrial Engineering, Mechanical Engineering or a related field.