Quality Engineer - Medical Device - Kelly Services : Job Details

#x 9; Identify, communicate, and implement quality improvements and solutions. Manage corrective actions, including customer complaints and internal issues: Investigate root causes using Lean, Six Sigma, and statistical tools. Coordinate sustainable corrective/preventative actions. Document findings and update customer portals and internal systems. Lead the non-conformance process: Evaluate suspect products and recommend disposition. Coordinate containment, returns (RM - As), and rework activities. Collaborate with customers on waivers or deviations. Maintain the Quality Management System (QMS) in compliance with ISO 13485 and regulatory standards: Support internal and external audits and corrective actions. Contribute to product development and realization: Participate in design reviews, process planning, and risk analysis. Review key product characteristics, gaging methods, and GD&T. Review and approve Engineering Change Notices: Update quality documentation and control plans. Proces...Quality Engineer, Medical, Device, Engineer, Technology, Staffing