Lead Engineer
HCL TECHNOLOGIES
Madurai
12.2017
- Working under DePuy Synthes (SPINE, TRAUMA, CMF & Joints platforms) for Tech file Remediation project
- Prepared Product Quality Plan (PQP) Documents in Remediation activities
- In De - Risking Project Single handedly managed the entire data collection activities as per customer requirements for all Op - Cos and collected all of the part information that is accessible in PLMs
- Prepared Manufacturing Process Information's for Mechanical devices (Medical) as per regulations and standards
- Hold Responsibility as a Reviewer for Manufacturing Process Verification and Validation for Medical Devices
- Performed process investigations and troubleshooting for all applicable manufacturing processes, Support operations in corrective actions planning and execution
- Responsible for generating process verification protocols and reports, process validation protocols and reports, process FMEA and Manufacturing instructions, Control Plans, Manufacturing material lists with SDS, Material Certificate and routers
- Create and review Production Risk Management (PRM), Process Failure Mode and Effect Analysis (PFMEA), Design and Clinical Risk Management (DCRM), Risk Management Plan (RMP) and Risk Management Report (RMR) for Trauma, SPINE, CMF systems to comply with the current FDA, EU MDR and ISO standards
- I Have Knowledge in PLM change management processes
- (Windchill - CR and CN, Agile - DCR and DCO)
- Utilize the Tolerance stack-up analysis to ensure that the components are operating properly
- Investigation of the complaint based on the summary in Post market surveillance report thus determining the occurrence rating and to estimate the risk level
- Post market activity for finding the root cause of a product failure to determine the occurrence rating and to estimate the risk level
- Participation in updating and ensuring that all failure modes and corresponding Hazards are covered in PRM, and risk is mitigated to acceptable levels
- Perform process audits and identify gaps in the supplier's processes and work with the supplier in closing the gaps and improving the manufacturing processes
- Follow-up of the actions and closure of the actions are the responsibility of the SQE
- I have experience in coordinating a cross functional team to accomplish an objective
- Experience in using PLMs like Agile, Windchill, SAP, JDE, Tungsten, Adaptiv for creating and routing the PRM document
- During my time as a DPA, I had solid QMS knowledge including Validation of resource skill level, Defect Prevention, Defect Goal Analysis and CAPA implementation.