• Perform monthly audits for Project compliance to internal Medical QMS process and OMS (Organizational Management System) process.• Participated in CMMI Level 5 v1.3 SCAMPI assessments, ISO 9001 Surveillance audit, and ISO 13485 Surveillance audit.• Conduct Internal Quality Audit for projects based on ISO 9001 and ISO 13485 QMS.• Facilitated project team for root cause analysis and CAPA proposal for Customer audit NCs, Customer escalations, low customer feedback, IQA audit… Show more • Perform monthly audits for Project compliance to internal Medical QMS process and OMS (Organizational Management System) process.• Participated in CMMI Level 5 v1.3 SCAMPI assessments, ISO 9001 Surveillance audit, and ISO 13485 Surveillance audit.• Conduct Internal Quality Audit for projects based on ISO 9001 and ISO 13485 QMS.• Facilitated project team for root cause analysis and CAPA proposal for Customer audit NCs, Customer escalations, low customer feedback, IQA audit NCs.• Analysis of customer feedback and review of action plan for the improvements suggested by customer.• Process database collection-Lessons learnt, Best practices, Reusable components, Risk Database, DAR database.• Participated in DU (Delivery Unit) reviews and presented Quality deck on the current project status against QMS process. • Metrics data collection, Analysis and deck preparation for Management Review meeting.• Perform QA review of metrics data in metrics tool. • Mentored the project teams in implementing the defined organizational processes.• BAF(Business Aligned Framework) awareness session is taken to project team and promoted PMSmart-BAF tool usage.• Prepare & implement Project management plan, Quality Assurance Plan, Configuration management plan, Mechanical Development Plan at project level.• Applying "Process Performance Models" in projects.• Monitoring and Tracking of Sub-process metrics aligned to business needs of customer.• Good knowledge in Mechanical Development Life Cycle and Project management. Show less

Quality Operations• Carried out Validation of Manufacturing Line with all associated performances for products and processes.• Adept in handling Customer complaint with the focus on horizontal deployment of actions across manufacturing related to Quality. • Executing energy saving & other cost saving measures with suitable modifications in process.• Developing and implementing plans & schedules for Quality Operations.• Conducted PPAP trials and samples followed by handing… Show more Quality Operations• Carried out Validation of Manufacturing Line with all associated performances for products and processes.• Adept in handling Customer complaint with the focus on horizontal deployment of actions across manufacturing related to Quality. • Executing energy saving & other cost saving measures with suitable modifications in process.• Developing and implementing plans & schedules for Quality Operations.• Conducted PPAP trials and samples followed by handing over of manufacturing lines for run at rate for new processesInstallation & Commissioning• Co-ordination extended for installation and commissioning of Motor Manufacturing Line, followed by trial runs with Process and Process Validation.Process Improvements• Carried out Capability studies for equipment and processes • Implemented POKA YOKE systems for critical and non-critical equipments• Reviewing existing processes and re-designing for enhancing operational efficacy • Identifying the areas of obstruction/ quality failures and advising on system and process changes for qualitative improvement along with energy conservation.Noteworthy Initiatives• Taken responsibilities to identify time lags ,non-value-added steps and trouble spots and provided solutions • Played a pivotal role in establishing a World Class Quality Line to be on par with the Best Manufacturing Systems around the World. . Show less