A Quality Engineer with around 4 years of experience in Quality Assurance and Process Improvement, specializing in ISO 9001:2015 compliance and possessing good knowledge of ISO 13485:2016, FDA 21 CFR Part 820, and 21 CFR Part 11.
Proven track record in leading quality improvement projects, driving cost savings, enhancing operational efficiency, and reducing product defects across multiple plant operations.
Adept at identifying root causes of quality issues, implementing corrective actions, and delivering measurable results, including energy conservation and eliminating rejections.
Good in statistical analysis (e.g., Minitab, SPC) and skilled in cross-functional coordination, driving data-driven process improvements and successful implementation of process transformations that enhance operational efficiency and product quality.
An effective communicator with capability to think out of box & updated with current technological advances; possess analytical thinking and strong innovative & problem-solving capability.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Engineer-Quality Department
Nordex India Manufacturing Pvt.Ltd
Chennai
07.2023 - Current
Conduct quality checks throughout the manufacturing process to ensure adherence to work/process instructions, identifying and addressing defects to maintain high-quality standards.
Ensure product excellence by leading rigorous quality checks, aligning with ISO 9001:2015 standards.
Oversee the collection, analysis, and interpretation of quality related data from various systems and processes involving use of statistical tools and techniques to identify trends, patterns, and opportunities for improvement.
Collaborate with cross-functional teams (CFT) to identify and resolve quality issues, proposing solutions to enhance overall product quality.
Utilize problem-solving tools, such as 8D techniques, to identify root causes of issues and preparing CAPA.
Lead internal audits as per company policies, issuing non-conformances, verifying corrective actions, and ensuring continuous improvement based on audit results.
Ensuring CAPA compliance and conducting training.
Initiate and oversee quality improvement projects, applying Six Sigma and DMAIC methodologies to achieve measurable enhancements.
Performing an inspection to verify the compliance of production processes with established procedural standards to improve the reliability of the product/process.
Preparing and presenting CAPA reports.
Engineer-Quality and Outbound Logistics
LM Wind Power Blades (I) Pvt. Ltd.
Halol
03.2021 - 07.2023
Coordinated with suppliers on process improvement initiatives, ensuring consistent product quality and compliance with customer requirements..
Demonstrated comprehensive understanding of QA fundamentals to ensure adherence to quality standards and drive process improvement initiatives
Played a key role in change management related to quality systems which includes assessing the impact of changes, ensuring stakeholders are trained, and maintaining continuity in quality standards.
Collaborated with global teams and cross-functional plant teams to drive process improvement(In Blade Components).
Applied strong communication skills to effectively convey technical information through written reports and presentations.
Maintaining close coordination with customers, addressing issues like claims and delivering customer centric solution.
Prepared and presented project reports to senior management, ensuring clarity on project milestones, outcomes, and areas for improvement.
Servered as the primary contact for continuous improvement initiatives and exploring opportunities for process optimization.
Engineer- Quality
New Life Steel Structure Pvt. Ltd.
Palghar
09.2020 - 12.2020
Intern-Production and Quality
Prabha Steel Industries Pvt. Ltd.
Vadodara
05.2019 - 06.2019
Education
Bachelor of Engineering - Mechanical
The Maharaja Sayajirao University
Baroda
10-2020
Diploma in Engineering - Mechanical
Gujarat Technological University
Gujarat
01.2017
Technical Skills & Tools
ISO 9001:2015 Compliance and Lead Auditing(TUV SUD Certified)
Integrated Management Systems (ISO 9001:2015, ISO 14001:2015, ISO 45001:2018)
Good Knowledge of Medical Device Regulation Compliances
Good Knowledge of ISO 13485:2016, FDA 21 CFR Part 820, and 21 CFR Part 11
Problem-Solving Methodologies (8D, Root Cause Analysis, Ishikawa)
Statistical Tools Analysis (Minitab, SPC)
Process Improvement and Optimization (Lean Six Sigma, DMAIC)
Good at Microsoft Office Suite (Excel, Word, PowerPoint, Outlook), with advanced Excel skills
Axapta 2012 and Power BI (Data Visualization and Business Intelligence) expertise
Core Competencies
Process Optimization: Driving continuous improvement through Lean Six Sigma & root cause analysis.
Cross-Functional Collaboration: Collaborating with teams to resolve quality issues and implement process improvements.
Quality Assurance & Process Optimization: Ensuring ISO compliance, driving quality improvements, and optimizing operational efficiency through data-driven analysis and problem-solving.
Certification
Certified ISO 9001:2015 QMS Lead Auditor
Certified in IMS (ISO 9001:2015, ISO 14001:2015, ISO 45001:2018)
Certified Lean Six Sigma Executive- Green Belt
Essentials of MiniTab Software
Microsoft Power BI Desktop for Business Intelligence
Failure Modes and Effects Analysis Certification
Certified in Basics of Total Quality Management from TATA STEEL
Accomplishments
Achieved a Defect reduction of 10% (from 44% to 34%) of Wind blade shell within brief period of time through targeted process improvements.
Improved Single Item Approval FTR from 12% to 19% in reference to Wind blade shell, ensuring higher product quality and reduced rework by enhancing the approval process and cross-functional collaboration.
Improved FPY from 85% to 88%, driving a 3% increase in production quality, through effective collaboration with cross-functional teams to identify root causes and implement process improvements.
Developed and executed process improvement strategies that led to cost savings of $0.766K per blade through waste reduction and optimized resource utilization.
Received recognition through an Impact Award for demonstrating exceptional project management skills in implementing a project for a completely new blade(LM76.5P-Epoxy) within a constrained timeline.
Conferred with Impact Award (Bravo Award) by India Ops Head for team collaboration: - Highest ever dispatches across all the plants in a single month and thus resulted in Rev Rec of Approx. $32.15Mn for Plant (333 blades dispatches in a single month— DEC’21)
Engineer-Process/ECM/Continuous Improvement Specialist at Nordex India Manufacturing PVT LTDEngineer-Process/ECM/Continuous Improvement Specialist at Nordex India Manufacturing PVT LTD
Senior Global Process Engineer at Nordex India Manufacturing Private LimitedSenior Global Process Engineer at Nordex India Manufacturing Private Limited