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.

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.

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.

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
• 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.

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.

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.

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 of.

H.S.C, Science, 7

pune university