Supplier Quality Engineer II

Quality Management RoleDevelop, communicate, and manage a strategy/plan for addressing finished goods capability deficiencies, etc.Ensure proper approval and documentation practices are followed.Define and manage the process for growing effective partnerships with preferred contract manufacturers.Develops and prioritizes an auditing schedule.Assist in establishing supplier quality agreements.Delivers strategy on non-conformance management including Supplier Change Requests, Supplier Corrective Actions, and complaint investigations. Demonstrate knowledge of domestic and international requirements and standards. Support internal, corporate, notified body, FDA, and other audits.Collaborate with contract manufacturers to evaluate supplier scorecards and address low-performing suppliers with appropriate corrective action plans.Provide Pre-Market Quality Engineering support to New Product Development.Drive Quality in collaboration with cross-functional stakeholders and contract manufacturers where necessary.Evaluate contract manufacturers 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.