Praveen Kumar Email & Phone Number

Pune, Mh, In

Pune, Maharashtra, India

Aurangabad, Maharashtra

• Process monitoring and control for all the critical manufacturing process, including implementation of statistical process control and improvement through capability analysis• Use Design & Quality Engineering tools for the New Product Development and Design changes to existing products/Processes/Packages throughout the product lifecycle.• Identifying potential risk in manufacturing process through risk management process to prevent unanticipated failure modes and ensure capability using risk assessment tools and methods.• Support quality improvement initiatives such as process and product characterizations that lead to continuous or cost improvements.• support and approval of the Design & Development Plan, Design Requirements Matrix (DRM), Design Review Checklist, Support design verification, validation and transfer activities and DHF throughout the project as per applicable design control procedures.• Support Operations, Engineering in executing process specifications, process validations, process control and process risk management.• Support Operations, QA in the investigation and correction of process failures.• Execute and implement effective change control• Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, WHO GMP,,Schedule M etc.• Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) & MDR including providing support during internal and external audits.• Review results of area audits to ensure that corrective and preventive actions are adequate.• Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.• Supports new product introduction as part of design transfer.

Delhi

• Performing audits (product, process and factory) as per the local procedure and ISO requirement and assisting the supplier to close the non conformance identified during the audit• Coordinating with the suppliers to effectively eliminate the non-conformances identified during the audit• Providing training and empowering the supplier to conduct self-inspection for the products developed • Planning audit for the supplier’s factory, identifying key areas for improvement and developing the supplier with respect to quality on the manufacturing area as per local procedure• Handling:o Technical discussion with the supplier on the understanding of technical requirements and coordinating with engineers and suppliers for changes in the packaging and product designo Customer complaints with quality tools (7QC, FMEA 8D method) and effectively closing the issues with proper measures • Exhibiting leadership skills by executing programs by coordinating with engineers in China and supplier in India

Mahim, Mumbai

• Developed new procedure and strengthened the existing systems by updating the procedure for the improvement of Quality Management System as per the ISO requirement• Conducted management review & internal audit and timely follow- up on the completion of action points• Played a key role in online document management system development for system and project quality• Developed and executed verification, validation plans & test methods for the mechanical parts of the new products• Performed implementation of Quality Management System for the new product developed and on-going projects• Reviewed the design drawings for its GD & T as per ASTM standards and coordinated with suppliers in developing concrete corrective actions for any failures during production or during prototyping• Monitored the effectiveness of the corrective action taken• Played a key role in identifying root cause for a product failure from contract manufacturer and coordinated with the contractor for effective implementation of the corrective action taken

Nerul

• Monitored the final quality of the product dispatched to the customer• Developed quality plans for 3 different products • Coordinated with the production team to implement 5S in the production line• Conducted line audits to monitor the non-conformities in the production line• Monitored and maintained barcode records and uploaded in the internet • Recorded the FPR and scrap data in the production line

Master Of Business Administration - Mba, Operations Research

B.E., Mechanical

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