- Communicated impact on regulatory status, inventory, where used, purchase orders, sales orders, production orders, devices of a distributed product in the field or any other MRs to Business Units (BUs).- Clarified with the Quality Engineer and ER Manager the change class. Provides the defined class to the EC Initiator.- For ECs containing more approvers, host a recommended meeting with all EC approvers to drive approvals.- Coordinated a cross-functional team meeting in case the… Show more - Communicated impact on regulatory status, inventory, where used, purchase orders, sales orders, production orders, devices of a distributed product in the field or any other MRs to Business Units (BUs).- Clarified with the Quality Engineer and ER Manager the change class. Provides the defined class to the EC Initiator.- For ECs containing more approvers, host a recommended meeting with all EC approvers to drive approvals.- Coordinated a cross-functional team meeting in case the implementation of action items cannot be completed as stated in the EC or as agreed upfront. - Recommended team members are Supply Chain Engineering, DHR Support, Product Configuration Manager, Order Processing, Production Controller and Planning.- Updated the work instructions for products and Packaging overview documents newly released products/removed from service parts.- Ensured Cross-Entity implementation, If an EC impacts more than one MR Entity, the Owner and MR Manager determine and resolve any issue related to MR specific implementation steps.- Completed the Part setup for process for eDMR.- Worked on discontinuation process from the global market of products and sub-assemblies.- Worked on Part data setting, Product/Part obsolescence process, Product country release status settings and Product country release status using exception and waiver process.- Ensured the BOM protocol and eDS protocol reports and link the respective products.- Prepared the Scrap Cost estimation using SAP and Scrap approval form to get the approval from top management, based on the scarp process.- Worked on Windchill, eDHT, SAP and eDMR, to verify the documents.- Worked on the product service related process like CM released, CLS status change, Part comment update, End of life Setting for products/parts, creation of new part and product, MR extension process to multiple entities, Supported the OPDM update documents and all relevant process. Show less

Role&Contribution:- Develop clear, accurate and complete document content.- Assess changes for impact and transition planning done where applicable prior to implementation.- Ensure proper document training is provided.- Create, maintain, and/or obsolete documentation in accordance with the requirements set forth in this document.- Bring documentation issues to the next higher level of management.- Responsible for creating, managing, and ensuring implementation of the… Show more Role&Contribution:- Develop clear, accurate and complete document content.- Assess changes for impact and transition planning done where applicable prior to implementation.- Ensure proper document training is provided.- Create, maintain, and/or obsolete documentation in accordance with the requirements set forth in this document.- Bring documentation issues to the next higher level of management.- Responsible for creating, managing, and ensuring implementation of the EC- Owner of the Project Plan for Tool Validation.- Established the Development Team and the Review Team, including the assignment of key roles in all relevant functions Responsible to establish a detailed tool design including all requirements.Translation of the requirements into the design specifications and ensure that the design is robust, executed according to defined coding or configuration standards, and appropriately tested according to the system risk.- Implemented the tool and validated the design output.- Executed the tool Design Transfer process into final environment.- Ensure the system is monitored and maintained in a state of control in daily use including control of access by users and reporting of unauthorized access if applicable.- Assigned to different people for pre-release and post-release activities or even during tool design and validation procedure Owner of the Project Plan.- Reserve Engineering Change (EC) number and initiate changes to existing DMR or sets up new Product.- For ECs containing more approvers, host a recommended meeting with all EC approvers to drive approvals.- Created the purchasing specification and assembly process for newly released product- Completed the Part setup for process for eDMR- Communicate the supplier to get the PCN and SICR reports on time- Prepared the FAI plan and verified the FAR report from Supplier, and communicate the Gaps in the report to supplier to make sure the report is correct. Show less

Role & Contribution:• Review and classify records as a complaint, non-complaint or duplicate.• Performs initial reportability decision.• Assign symptom coding.• Assign complaints to complaint investigator.• Collects, reviews and analyzes data to understand the complaint issue.• Completes the complaint investigation/triage.• Escalates issues for further investigations, actions or reviews.• Mentoring new team members to bring out as per the project… Show more Role & Contribution:• Review and classify records as a complaint, non-complaint or duplicate.• Performs initial reportability decision.• Assign symptom coding.• Assign complaints to complaint investigator.• Collects, reviews and analyzes data to understand the complaint issue.• Completes the complaint investigation/triage.• Escalates issues for further investigations, actions or reviews.• Mentoring new team members to bring out as per the project requirement.• Identified potential product complaint communications received as Feedback (FBD), Direct Call (DC) or Service Order (SO) records in TrackWise for disposition.• Performed assessment of communication to determine if it is a complaint.• Conducted Good Faith Efforts (GFEs) to determine initial reportability decision.• Performed and documented initial MDR/Vigilance reportability decision• Dispositioned communication as a complaint, a complaint requiring further investigation, or a non-complaint.• Performed Tier assessment of complaint: T1, T2, T3, T4 and routes records accordingly• Performed Duplicate/Continuation check• Identified and removed Patient Private Information (if possible).• Assigned Symptom Code and Failure Codes and updating the customer resolution depending upon FSE notes. • Hands on experience in Trackwise, Salesforce, SAP database.• Selection of Hazard codes (Hazard category and Hazard situation) and severity as per reported harm to the customer.• Completed training and Submitted complaint records for review.• Evaluated complaint record according to this protocol and applicable procedures.• Investigated complaints, ensuring all required fields as stated in the applicable procedures are completed. Provides rationale for any missing information in the appropriate field(s).• Escalated any complaint meeting the definition of a Reportable complaint to Complaint Team Lead and SME. Show less

Role & Contribution: • Perform GAP analysis of FAI reports in conjunction with FDA guidelines (510(K) requirements).• Responsible for reviewing FAI reports as per quality plans, evaluating FAI characteristics and determining if FAI data complies with customer specification and FDA guidelines.• Mentoring new team members to bring out as per the project requirement.• Based on process capability & response time to make decision on how to execute the FAI. • Collaborate with… Show more Role & Contribution: • Perform GAP analysis of FAI reports in conjunction with FDA guidelines (510(K) requirements).• Responsible for reviewing FAI reports as per quality plans, evaluating FAI characteristics and determining if FAI data complies with customer specification and FDA guidelines.• Mentoring new team members to bring out as per the project requirement.• Based on process capability & response time to make decision on how to execute the FAI. • Collaborate with the customer supply chain / BU responsible to find existing FAI's and resolve any or all issues.• Perform GAP analysis on available FAI reports in eDMR and define action plan to resolve FAI issues.• Follow up with onsite team to resolve the Queries/Gaps identified in the FAI report.• Define the need for QN and assist QN coordinator in raising Quality Notifications (QN).• Creating ballooned drawings / specification and FAI data sheets to help the quality inspector to capture FAI inspection results.• Create status reports and dash board to monitor overall progress of individual item in-scope.• Create checklist in accordance with quality plan to assure the quality of the work getting delivered to customer.• Experience with AS 9100, AS 9102 (Ballooning the engineering drawing as per requirement of the parts and preparing Form-1, Form-2, Form-3 as per AS9102 REV B standards) FAI Requirements.• Supporting APQP process for qualifying the new product.• Supporting for Critical to Quality (CTQ) activities.• Minutes of Meeting (MOM) preparation and circulated to team members.• Conducted the Knowledge Sharing session with Onsite & Offshore teams to keep the team updated. Show less

Role & Contribution: • Verify the quality related issues of Testing Equipment’s such as Cables, HT/LT Panels and PCBs, Batteries and Electrical and Electronics assemblies.• Preparing the Checklist for quality inspection.• Check the product is manufactured as per the quality requirement which are supplied by the supplier.• Studying of electrical Wiring diagram and execution tasks.• UPS and RAW power installation.• Control cable for DG Panel & LT… Show more Role & Contribution: • Verify the quality related issues of Testing Equipment’s such as Cables, HT/LT Panels and PCBs, Batteries and Electrical and Electronics assemblies.• Preparing the Checklist for quality inspection.• Check the product is manufactured as per the quality requirement which are supplied by the supplier.• Studying of electrical Wiring diagram and execution tasks.• UPS and RAW power installation.• Control cable for DG Panel & LT Panels.• Industrial lighting installation and DB Erection and Dressing.• Installation of Different Light Fixtures in work stations, corridors, etc.,• Create and execute a work plan.• Customer interaction and point of contact for quality related issues testing of Equipment’s such as Cables, HT and LT Panels.• Supervising the cable Erection and termination as per standards coordinate with consultant• Developed and Commissioned DCS systems in various consumers.• Inspected the various types electrical and electronics product like Printed Circuit Board Assemblies, Power Supplies, Cables and Batteries.• Fire production system and Fire alarm system testing.• Completed Erection and UG Cable Erection of High Mast Lights in various Corporations.• Prepared and documented the Checklist for quality inspection plan and report.• Conducted and completed the Third-party Inspection for all the Energy saving equipment.• Completed Erection and UG Cable Erection of Center median lights.• Reconstruction of High mast and Center Median Street lighting in various Corporations.• Completed LT cable Erection works in various industries.• Completed Energy saving Project for street lights in three Corporations.• Partially supported on Energy Efficiency projects of GOA and Andaman Projects.• Transformer Erection and control wiring schedule etc.• Feeder pillar erection wiring etc.• Completed testing of the Zigbee powered Individual Lamp Monitoring (ILM) devices.• Prepared and documented the Maintenance plan. Show less

Role & Contribution:• Maintaining a relationship with the customer.• Establishing management procedures. • Studying of electrical Wiring diagram, Manual and execution tasks.• Establishing the project initiation team & Plan.• Monitoring & Updating Project systematic Electrical documentation.• Continuous improvement in process and Circuits.• Electrical Circuit Design for Machine as Customer Requirement using Drives, Relays and MCB etc.,• Machine Control Panel… Show more Role & Contribution:• Maintaining a relationship with the customer.• Establishing management procedures. • Studying of electrical Wiring diagram, Manual and execution tasks.• Establishing the project initiation team & Plan.• Monitoring & Updating Project systematic Electrical documentation.• Continuous improvement in process and Circuits.• Electrical Circuit Design for Machine as Customer Requirement using Drives, Relays and MCB etc.,• Machine Control Panel Commissioning in the Customer Place.• Establishing the control panels to meet customer requirement.• Operation and Maintenance for SPM and CNC Machines. • Mentoring new team members to bring out as per the project requirement• Hydraulic Bale Press Machine Automation using the cyclic timer or PLC.• Rubber Molding and Injection Molding Machine Automation using Programmable Logic Controllers.• Foundry Machinery Automation using Programmable Logic Controllers (PLC).• Steering Control Panel Automation using cyclic timers and PLC devices.• Manufactured 800W/1400W, 50HZ/60HZ Cleaner Motor Testing Panel with the use of 20A Auto Transformer and High - Voltage Tester.• Soda Filling Machine Automation without using of Cyclic Timer.• Motor Endurance Panel and Chemical Plant Control Panel.• Bag Cutting machine automation using PLC, VFD drives and servo motors.• Automated the conveyors using the VFD drives.• Prepared of electrical Wiring diagram, Manual and execution process for all the PLC and Servo drive panels.• Involved in the development of various Control panels and Distributed Control Systems (DCS). • Inspected the various types electrical and electronics product like Printed Circuit Board Assemblies, Power Supplies, Cables and Batteries.• Fire production system and Fire alarm system testing.• Completed Erection and UG Cable Erection of High Mast Lights in various industries.• Transformer Erection and control wiring schedule etc• Prepared and documented the Maintenance plan. Show less