Ajit Kumar Yadav
Lead Engineer | HCL| Healthcare | Medical device | Regulatory affairs |Quality assurance ISO 13485 | PMS| Complaint handling I Complaints Investigations| EU-MDR | US FDA |
- Role
- Lead Engineer at HCLTech
- Location
- Chennai, TN, IN
- LinkedIn followers
- 500 followers
About Ajit Kumar Yadav
I have dedicated over 4.8+ years to the medical domain. My expertise extends to…
Experience
Lead Engineer
Dec 2024 — Present · Chennai, IN
Investigate the medical device complaints for various models and find the rootcause of the failure based on the SAP data.•Document the appropriate IMDRF codes for the failures.•Investigate the various types of complaints, such as service and non-service,including patient involvement and no patient involvement, and document theinvestigation results on Trackwise.•Provide technical guidelines to the team, track their productivity and quality,and manage the team in the absence of the lead.•Conduct the Knowledge Transfer session (KT) to the team related to products,processes, etc. Conduct the knowledge transfer session (KT) to the team relatedto products, processes, etc.•Doing the follow-ups with service engineers and country regional managers toget updates about the service details and pending work order details.
Education
SRM University
Bachelor of Technology
2016 — 2020
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