Pradip Warghude Email & Phone Number

Remote

Working as a Design Quality professional to support USFDA Class III Medical devices.Software Medical Devices Quality Assurance, 510K premarket submission, Cyber Security compliance for medical devices, DHF, Design review, Jira, traceability, risk management, IEC62304, ISO14971, Software life cycle management, new project development, DHF gap assessment,

Thane, Maharashtra, India

Global Quality representative on design core teams to support the design control process, including new product design, specification development and preparation, verification and validation, design changes, risk management, report preparation, technical documentation, and commercialization of productsAssesses written product and project documentation for compliance to applicable standards, regulations, internal requirements, and project goals.Asist with the assembly, control, and… Show more Global Quality representative on design core teams to support the design control process, including new product design, specification development and preparation, verification and validation, design changes, risk management, report preparation, technical documentation, and commercialization of productsAssesses written product and project documentation for compliance to applicable standards, regulations, internal requirements, and project goals.Asist with the assembly, control, and maintenance of product design history files, risk management files, DFMEA & FMEA and technical documentation.To Analyzes, draws conclusions from, and reviews test results to evaluate conformance to specifications and assess risk.Supports and participates in sustaining engineering projects, including quality initiatives and post market design changes and improvementsParticipates in the engineering change process for requests involving product or process change in PDM. Detail Gap analysis of the Existing DHF with IVDR Requirement.Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to design, material, and/or processActs as an effective leader or team member in supporting quality disciplines, decisions, and practicesWorked on the Product life cycle tool such as Agile, PDM, Jirra, SAP, Lotus, smartsheet.Suplier Quality task like First Article Insection report on PDM and Lotus. Show less

Thane, Maharashtra, India

To design, Implement and monitor Quality Management System.To review, provide technical inputs and approve the Qualification and Validation Documents i.e. User Requirement Specification (URS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Process Validation (PV), Cleaning Validation (CV) Implements and monitors the standards of performances, continual quality improvement of medical services rendered.To provide Provide quality… Show more To design, Implement and monitor Quality Management System.To review, provide technical inputs and approve the Qualification and Validation Documents i.e. User Requirement Specification (URS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Process Validation (PV), Cleaning Validation (CV) Implements and monitors the standards of performances, continual quality improvement of medical services rendered.To provide Provide quality engineering support in project design, development and implementation phases.To Participate in design reviews and recommend improvements.To Identify technical risks and challenges and recommend corrective actions.To Oversee quality management system and prepare quality documentations.Adhere to company regulations and policies at all times.Working as a Management Representative for the ISO 13485 and ICMED 13485 Standrdas. Planning and organizing review meetings.Preparing, Reviewing of SOP’s and QSP’s and Manuals. Handling of deviation, change control, Show less

Navi Mumbai

Responsible for Quality assurance and regulation of class2b medical devices.Coordinate with notified body for ISO 13485: 2016, CE Mark certification audits , other regulatory workManaged the existing quality systems with integral quality documents including SOPs, WRSs and DSs in compliance with ISO 13485 and GMP requirements, while bringing fresh ideas for continuous improvement. Prepare and implement all mandatory documents as per ISO 13485 & CE standard’s requirements.… Show more Responsible for Quality assurance and regulation of class2b medical devices.Coordinate with notified body for ISO 13485: 2016, CE Mark certification audits , other regulatory workManaged the existing quality systems with integral quality documents including SOPs, WRSs and DSs in compliance with ISO 13485 and GMP requirements, while bringing fresh ideas for continuous improvement. Prepare and implement all mandatory documents as per ISO 13485 & CE standard’s requirements. Manage and contribute to the effective closure of internal/ external audit findings and customer complaints through the effective implementation of CAPA system.Preparation and planning of new product design and development process. Coordination with all departments for their documentation & regulatory compliance requirements. Show less

Mumbai Area, India

▪ Preparation of Technical File documentation for the various manufacturing process, Design History Files ,SOPs, Work instructions , Quality procedures, Risk Register updation in the Quality management system (ISO 13485).▪ Participates in internal & external audits of quality systems, processes, and products to ensure compliance with regulations and internal specifications.▪ Documenting current production procedures and create Company standards to improve the efficiency… Show more ▪ Preparation of Technical File documentation for the various manufacturing process, Design History Files ,SOPs, Work instructions , Quality procedures, Risk Register updation in the Quality management system (ISO 13485).▪ Participates in internal & external audits of quality systems, processes, and products to ensure compliance with regulations and internal specifications.▪ Documenting current production procedures and create Company standards to improve the efficiency of the Manufacturing Department. ▪ Design and development of the existing as well as new medical device to comply the standards (such as IEC60601-1 as well as country specific regulation).▪ Preparation & maintain Batch Manufacturing Record of product in accordance/Complience of QMS.▪ Performing Machine, Equipment (IQ,OQ,PQ) and Production Process Validation with protocol design.▪ To minimise overall production costs while maximizing productivity. Collect, analyze, summarize and present production and process data, information and trends to management. ▪ Development of product label and IFU’s as per country requirements.▪ Participate in the development of corrective and preventative action plans and coordinate closure of actions with assigned responsible parties. Assure and track the timely closing of all variances, CAPAs and audit findings.▪ Monitoring the critical manufacturing processes such as Physical testing & Chemical Testing of product, Sterilization, dose mapping, dose audit, sterility testing, bioburdon testing.▪ Source new equipment and material suppliers as required. ▪ Review internal operational facility layouts for process improvement. ▪ To Lead, develop and mentor the Production team of 20 members. Show less

Thane,Maharashtra,India

 FDA (India)Approved staff in Manufactruing,Quality Assurance and Physico-Chemical Testing. Successfully set and adaupt Scientific Quality Management System in organisation as per FDA Guidelines. Preparation of Batch Manufacturing Record at the end of Manufacturing with accordance/Complience of FDA,GMP Norms. Preparation/Revision Of Standard Operating Procedure for every activity in manufacturing as per GMP. Documenation of Job slip to BMR Processes such as Line clearance… Show more  FDA (India)Approved staff in Manufactruing,Quality Assurance and Physico-Chemical Testing. Successfully set and adaupt Scientific Quality Management System in organisation as per FDA Guidelines. Preparation of Batch Manufacturing Record at the end of Manufacturing with accordance/Complience of FDA,GMP Norms. Preparation/Revision Of Standard Operating Procedure for every activity in manufacturing as per GMP. Documenation of Job slip to BMR Processes such as Line clearance for manufacuring,Raw material testing,BIN card, Inprocess checking,Job Card,Machine Logbook record,Quality control Approval check,Final Inspection Record with full accountability and authority. Handling FDA Audit, ISO Regulatory affair in organization. Preparation of Quality Agreement for outsource Processes,experience in process validation report,certication of analysis (COA), Callibration report, sterilization process. Having an experience of facing 8 times FDA Audit with compliance report submission. Provide training to employee regarding QMS,GMP,SAFTY, Lean, Kaizen,5S, Kanban. Successfully set Organisation chart as per QMS. Successfully developed Batch Release Process, Product Recall, Customer Complaints Handling,Cleaning,product packing AHU,Training,Self Inspection, CGMP Processes .  Monitor overall system,processes and make sure whether quality policy of the organization achieved or not.If not then corrective action plan development Show less

Mumbai Area, India

First class Graduate Production Engineer with more than 2years+experience in the area of Production, Production planning and control,Design & development, Inventory management as well as Purchase.Having experience in planning of CNC manufacturing of medical devices.I am FDA Certified approved staff in manufacturing,1.Production Planning and Control-Daily interaction with head office,sales department regarding work Purchase order and production status .Generation and execution… Show more First class Graduate Production Engineer with more than 2years+experience in the area of Production, Production planning and control,Design & development, Inventory management as well as Purchase.Having experience in planning of CNC manufacturing of medical devices.I am FDA Certified approved staff in manufacturing,1.Production Planning and Control-Daily interaction with head office,sales department regarding work Purchase order and production status .Generation and execution of raw material,tooling requirements in quantity and grade as per order received.Scheduling workload as per planning list ensuring that production delivers are meeting to dispatch plan. Product history cards to production,Maintain the record of raw material such that Bin Cards. Bill of Material, hardness test and chemical test report.Preparation of Standard operating Pocedure(SOP) for each product.2.Design and development Preparation of 2D,3D drawing of components on design software AutoCAD & Powershape .Development of new products and Tooling fixture desin and change in existing design by customer requirent.Generate CNC program manualy or on software of DelCAM and3.Production-Supervising team of 25 workers,Assign the job to each machine and worker.Monitoring and controlling the operator and maintain the productivity, Ensure each workers job cards,machine workbook as per cycle time.Expertise in Settting & operation of the CNC machines-CNC,VMC,HMC Grinding ,Turning.Practical experience & knowledge of cutting tools,tooling used on above machines.Programming experience in Fanuc,Mazatrol control system.Experience in maintenance of all the above mentioned machines like machine breakdown,periodic maintenance with scheduled sheets.Design of tooling,fixtures, gauges,procure if neededImplementation of Kaizen,5S, Kanban, techniques in the production.Maintain the ISO,FDA documentation& Standards Audit.Maintain the production reports, process sheets,product history Show less

Bachelor Of Engineering (Be), Production Engineering, 62.75% Agreegate

I have learn the basics of engineering fundamentals of all the manufacturing processes in terms of Industrial applications and roll.

H.S.C, Science, 7

pune university