Quality Engineer

Quality Engineer – Job Summary

1. Qualifications: Bachelor's degree in Engineering, Quality, Science, or a related technical field; 2–5 years of manufacturing engineering or quality assurance experience; knowledge of FDA regulations, ISO 13485, change control, document control, and ERP/MRP systems. CQE, Lean, or Six Sigma certification is preferred.
2. Ensure compliance with ISO 13485, FDA regulations, customer requirements, and Quality Management System (QMS) procedures.
3. Review engineering drawings, specifications, BOMs, work instructions, inspection criteria, labeling, and packaging documentation.
4. Support new product development, design transfer, production readiness, and manufacturing launch activities.
5. Develop and maintain FMEA, CTQs, control plans, inspection strategies, sampling plans, PPAP, and FAI documentation.
6. Apply statistical tools, including GR&R, process capability analysis, measurement systems, and data evaluation.
7. Plan, execute, and document IQ/OQ/PQ, process validation, Test Method Validation (TMV), and other qualification activities.
8. Support production quality, DHR/product release reviews, containment, rework, reinspection, and Material Review Board (MRB) dispositions.
9. Investigate nonconformances, customer complaints/RMAs, deviations, and audit findings; support root cause analysis and CAPA.
10. Analyze quality and manufacturing data, identify trends, drive risk-based improvements, and support cross-functional quality activities.