Rahul Suryawanshi
Qms Specialist @Philips
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WORK HISTORY
Qms Specialist @Philips
Pune, IN
Working as a QMS Specialist in DXR-0015 BU and making analignment with global stakeholders to comply withISO13485:2016, US FDA 510(k), EU MDR and closely work withR & D and Regulatory organization. Responsible for to Develop, implement, and maintain Quality Management System (QMS) in accordance with ISO 13485 and other applicable regulatory standards. Working closely with Regulatory Affairs, R&D, and Manufacturing teams to align quality processes with compliance requirements. Preparing and maintaining Standard Operating Procedures (SOPs), Work Instructions (WIs), Forms, Templates, Guidelines and Quality Documentation to meet regulatory requirements. Investigate and resolve Non-Conformance Reports (NCRs), Corrective and Preventive Actions (CAPA), and customer complaints. Strong proven experience in simplifying/reviewing DHFs,Design requirements, IFU, Risk Managements, V&V activitiesetc. Working on the different tools such as Wind-chill, ARIS, Citrix, WOW, Plot View, etc. Skilled in managing end-to-end Risk Management processes as per ISO 14971, from hazard identification to mitigation and validation. Expertise in QMS, Change Process and plans, Risk Management. Ensured compliance with FDA 21 CFR Part 820, ISO 13485, and EU MDR by validating records and responding to auditor queries. Worked on Risk Management file and devised documents such as Risk Management plans and reports, Hazard analysis, FMEAs as per ISO 14971. Leading and participate in cross-plant and corporate project teams in NC & CAPA and Quality System Improvement. As a Change plan manager responsible for migration of update documents from different stakeholders with their latest revision in ARIS as change Proficient in Data visualization techniques using MS Excel and Power BI, transforming complex data into actionable insights for stakeholders.
EDUCATION
Savitribai Phule Pune University
Bachelor's degree
ABOUT RAHUL SURYAWANSHI
Accomplished professional with over 10+ years of experience in the medical device industry, specializing in Design Quality Assurance and Regulatory Affairs. • Proficient in developing project timelines, risk assessments, and resource allocation plans to ensure efficient execution of deliverables. • Managed and mentored a team, providing technical guidance, fostering skill development, and ensuring adherence to industry best practices for improved efficiency and quality. • Provided back-room support during FDA inspections and internal quality audits, collaborated with cross-functional teams to gather, review, and provide accurate documentation requested by auditors. • Ensured compliance with FDA 21 CFR Part 820, ISO 13485, and EU MDR by validating records and responding to auditor queries. • Ensured design control compliance for medical devices per ISO 13485, FDA 21 CFR Part 820, EU MDR, and IEC 62366. • Skilled in managing end-to-end Risk Management processes as per ISO 14971, from hazard identification to mitigation and validation. • Extensive experience in Vigilance Reporting, ensuring compliance with 21 CFR Parts 803 and IMDRF standards. • Expertise in developing and reviewing product labels and Instructions for Use (IFUs) in compliance with EU-MDR and ISO 15223-1. • Proficient in Verification & Validation processes, ensuring adherence to FDA and ISO 13485. • Conversant with Mechanical CAD software – CATIA V5, AutoCAD. • Experience in Structural Analysis (Static Strength Analysis) by using Ansys. • Extensive usage of GD & T and Tolerance Stack-up. • Proficient in Data visualization techniques using MS Excel and Power BI, transforming complex data into actionable insights for stakeholders. • Demonstrates exceptional problem-solving skills, cross-functional collaboration, and a commitment to driving continuous improvement.
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