Jithin M P
Senior Quality Engineer at Medtronic | Quality & Regulatory Professional | Medical Devices & IVD | Specializing in QMS/TQM, Risk, KPI Analytics, Audit & Compliance Excellence | Certified Internal Auditor
- Role
- Senior Quality Engineer at Medtronic
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Jithin M P
Accomplished, results-driven Quality & Regulatory professional with a strong track record and over 8 years of experience in the medical devices and in-vitro diagnostics (IVD) industry. Specializing in Total Quality Management (TQM), Quality Management Systems (QMS), Risk Management, Post-Market Surveillance (PMS), Device/Vigilance Reporting, and Regulatory Compliance across global markets.Certified Internal Auditor with proven expertise in leading end-to-end post-commercialization activities, including Complaints Management, Post-Market Surveillance, Device Reporting (US FDA & EMA-EU), Product Sustenance, Audit Management, KPI Analytics, Metrics Management, and Continuous Improvement initiatives. Experienced in authoring and reviewing critical regulatory documents and technical files for medical devices & IVDs, supporting product safety and lifecycle management. Adept at aligning quality strategies with business objectives while maintaining compliance with ISO 13485:2016, ISO 14971:2019, ISO 9001:2015, IEC 62366-1:2015, and global regulatory frameworks, including US FDA CDRH, EU MDR/IVDR (2017/745-746), MDD (93/42/EEC) and CDSCO.Demonstrates strong leadership and cross-functional collaboration, working seamlessly with R&D, Engineering, Manufacturing, Quality, and Regulatory teams to drive audit readiness, CAPA management, and risk mitigation. Highly proficient in leveraging tools like Power BI, Tableau, and Qlik Sense for metrics management, Key Performance Indicators (KPI) reporting and performance visualization.Holds a Bachelor’s degree in Mechanical Engineering and industry-recognized quality certifications, with a passion for driving quality excellence, ensuring product safety and compliance across the product lifecycle.Open to opportunities where I can contribute my expertise in quality assurance and regulatory affairs to drive compliance and continuous improvement.
Experience
Senior Quality Engineer
Sep 2025 — Present · Hyderabad, IN
Post Market Quality (PMQ) and Risk Sustenance - Cardiac Surgery
Education
Sir M Visvesvaraya Institute Of Technology
Bachelor of Engineering - BE, Mechanical Engineering
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