Mayank Kumar

Experience

1. Senior Quality Assurance Engineer

   Translumina Therapeutics

   Jul 2025 — Present · IN

   Implemented quality improvement initiatives in QMS, Assembly Area and Blow molding processes, resulting in zero rejections and significant reduction in defect rate.Conducted thorough root cause analysis of defects and worked with tool room and design teams to implement corrective actions, ensuring prompt resolution of quality issues.Developed and implemented effective quality control measures to ensure compliance with ISO 13485 and FDA guidelines.Investigated and resolved customer complaints related to product quality, resulting in improved customer satisfaction and loyalty.Monitored critical dimensions of parts using Optical Gaging Products (OGP) to ensure compliance with design specifications and regulatory requirements.Conducted thorough validation of new machines and molds, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ), to ensure that they meet design specifications and functional requirements.Performed revalidation of machine performance after changes, modifications, or upgrades to ensure continued compliance with regulatory requirements and design specifications.Investigated customer complaints to identify root causes, includingCollaborating with production teams to identify potential causes and implement corrective actionsImplementing corrective actions to prevent similar issues from occurring in the future.Verifying the effectiveness of corrective actions through testing and validationEnsured that all customer complaints were documented and recorded in accordance with regulatory requirements and company procedures.Managed supplier quality by:Conducting regular audits of suppliers to ensure compliance with quality and regulatory requirementsEvaluating supplier performance based on metrics such as defect rate and material quality.View and Approved BMR.

Education

• Modern Institute of Technology & Research Centre,Alwar

  BTech - Bachelor of Technology, Mechanical Engineering

  2014 — 2018