Ileshkumar Sheth

Results-driven Quality professional with experience in ISO 9001, ISO 13485, FDA, and cGMP regulated manufacturing environments. Skilled in quality inspections, process audits, root cause analysis, non-conformance management, SPC, and continuous improvement initiatives. Experienced in supporting quality systems and collaborating cross-functionally to improve product quality, compliance, and manufacturing efficiency within cleanroom and medical device manufacturing operations.

Quality Technician at Comar (2026-04 – Present)

• Verified compliance of finished assemblies and molded components with engineering drawings, GD&T requirements, ISO 9001, ISO 13485, FDA, and cGMP standards through in-process, first article, and final inspections.
• Led investigations and resolution of non-conforming materials using RCCA methodologies including 5-Why, Fishbone Diagram, and 8D, ensuring effective containment, corrective actions, and continuous process improvement.
• Partnered cross-functionally with Operations, Engineering, and R&D teams to drive Lean Manufacturing, 5S, SPC, and mistake-proofing initiatives that improved product quality and manufacturing efficiency.
• Conducted process audits, floor inspections, and quality system reviews to ensure compliance with QMS procedures, cleanroom requirements, customer specifications, and regulatory standards in a medical device manufacturing environment.
• Utilized quality data analysis, KPI tracking, Gauge R&R, and inspection reporting tools including Microsoft Excel to identify trends, reduce defects, and support data-driven quality improvements.

Mechanical Engineer at Kgs Technology Group (2024-08 – 2026-04)

• Develop 3D CAD models and design machined, cast, sheet metal, and injection molded parts that meet functional requirements.
• Optimize part designs for fast and economical manufacturing using DFMA skills.
• Generate manufacturing drawings with GD&T including detailed part and assembly drawings with a complete BOM using SolidWorks.

Manufacturing Engineer at AliKraft Engineers Pvt Ltd (2021-06 – 2022-08)

• Led manufacturing operations for Rack & Pinion hoist systems, optimizing fabrication of components such as masts, cages, racks, and platforms for heavy industrial applications.
• Implemented lean manufacturing practices and 5S methodologies, reducing waste, improving floor organization, and increasing throughput by 15%.
• Utilized MES, CMMS, and SAP systems to manage production schedules, monitor work-in-progress (WIP), track maintenance, and issue work orders.
• Assisted in supply chain coordination by reviewing BOMs, tracking inventory levels, and working with procurement to ensure timely material availability.
• Developed and standardized Standard Operating Procedures (SOPs), work instructions, and quality protocols to ensure ISO 9001:2015 compliance.

Master of Science in Mechanical Engineering – Rowan University (2024-05)

Bachelor in Mechanical Engineering – Gujarat Technological University (2021-07)