Manju N

Experience

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  HCL Technologies

  Jan 2021 - Mar 2024

  Research Development Mechanical Engineer - Becton Dickinson

  A well organized, exceptionally detailed, diligent, and proactive character from being Quality Engineering, Quality Control, Quality Management System and Post Market Surveillance. Well versed and with in-depth knowledge in ISO 13485, FDA 21 CFR Part 820 regulation. Has full scale knowledge on Process Improvement, Lean Six Sigma Methodologies, Fishbone Diagram, CAPA, NC. Strong work ethic, quick learning, work across team and taking initiative to gather information and tools to get the project completed on time. Understanding in ISO 13485 (QMS), ISO 14971 (Risk Management), FDA design control procedures.3 years of experience as Quality Engineer for medical device Company with a proven record of producing top notch deliverables. Manage projects at each stage with diligent and attentive approach, carefully checking details, verifying calculations, and testing assumptions, risk management, Quality plan and report creation & Process Improvement. Skilled in training associate team members in quality management system principles and practices. Has full scale knowledge on Process Improvement, GD&T and Tolerance Stack Up analysis, Quality and Design Engineering, Change Management, CAPA and NC. Strong work ethic, quick learning, work across team and taking initiative to gather information and tools to get the project completed on time. Hardworking, honest, responsible and motivated individual looking for the good opportunities to enhance my skills.Strong experience in CAD drawings and label redlines and artwork design with respect to project scope.Experienced in gap assessments, MDR remediation, design verification protocols and reports, Additionally, expertise in delivering assessments like bio compatibility, clinical, packaging and stability.Skills:-PLM tools -Teamcenter, Windchill and MasterControl.Design tools- AUTO CAD, CATIA and Solidworks.Other Tools:- Microsoft Project Plan. Jira Software Show less

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  Tata Elxsi

  Mar 2024 - now

  Senior Engineer