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Hiring companyQuest Global

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Manufacturing Engineering Lead

Chennai,Tamil Nadu,India Full-time On-site

About the role

Manufacturing Engineering Team at Quest Global drives the transition of medical consumables and electromechanical devices from design to full-scale production. The Lead executes process improvements, develops validation protocols, and creates detailed work instructions while ensuring compliance with ISO 13485 and IEC 60601-1. Chennai, India, on-site role focusing on high‑volume manufacturing excellence.

What you’ll do

  • Execute process improvement activities
  • Develop and run IQ/OQ/PQ validation protocols
  • Create and maintain SOPs, work instructions, and technical specs
  • Perform root cause analysis and implement corrective actions
  • Facilitate PFMEA sessions and manage risk mitigation
  • Utilize PLM tools (Windchill/Teamcenter) and Jira for task tracking

What you’ll bring

  • 6-12 years manufacturing engineering experience
  • Bachelor's degree in Mechanical, Manufacturing, or Biomedical Engineering
  • Experience in medical device or regulated industry
  • Proficiency with DFM/DFA principles
  • Knowledge of ISO 13485 and IEC 60601-1 standards

Skills

Process DevelopmentDesign for ManufacturingDesign for AssemblyRoot Cause AnalysisIQ/OQ/PQ ValidationISO 13485 CompliancePLM ToolsJira

Education

Bachelor's