Job Summary: The Quality Engineer is responsible for ensuring that manufacturing processes, products, and systems comply with established quality standards, regulatory requirements, and customer specifications. This role supports continuous improvement initiatives, root cause analysis, and corrective and preventive actions (CAPA), while collaborating closely with production, engineering, and quality control teams. The Quality Engineer also supports audits and maintains compliance with ISO 9000 quality management system documentation. Key Responsibilities: Develop, implement, and maintain quality engineering processes to ensure products meet internal and external quality standards. Support and enforce compliance with quality management systems, including ISO 9000 / ISO 9001 documentation, procedures, and records. Analyze production and inspection data to identify trends, non-conformances, and opportunities for process improvement. Lead root cause investigations using quality tools (e.g., 5 Whys, Fishbone, Pareto analysis, FMEA) and implement CAPA. Collaborate with Quality Control Leads, inspectors, production, and engineering teams to resolve quality issues efficiently. Support internal and external audits (customer, regulatory, and ISO) by preparing documentation and responding to findings. Assist in the development, review, and control of work instructions, procedures, and quality records. Participate in new product introductions, process validations, and engineering change reviews from a quality perspective. Monitor supplier quality performance and support corrective actions as needed. Prepare and present quality metrics, reports, and improvement recommendations to management.
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Job Type
Full-time
Career Level
Mid Level