Yuvaraj B
Chennai
Summary
Results-driven Quality Engineer with a knack for high productivity and efficient task completion. Specialize in statistical process control, root cause analysis, and continuous improvement methodologies. Excel in communication, problem-solving, and teamwork to enhance product quality and process efficiency.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Quality Engineer
HCL Technologies
Chennai
07.2019 - Current
- Analyzed engineering changes to determine necessity of customer notification, drafted and issued required notification letters.
- Maintained close collaboration with the complaints handling team to ensure prompt resolutions for tracked and managed customer complaints.
- Aligned EURA with latest templates in accordance with ISO 14971:2019 as part of MDS MDR EURA Risk Remediation project.
- Ensured accurate summarization of CAPA reports by validating information on Problem Statement, Investigation, Root Cause Analysis (RCA), Action Plan implementation, and Effectiveness Review.
- Evaluated component material numbers based on the FERT (Finished Goods) list extracted from Bill of Material (BOM) and ensured proper linkage to respective specifications and associated documents.
- Verified completion of all Q6 Quality Notification (QN) tasks in eDHR, providing rationale with Q6 closure Memo for repair/damage on production line products.
- Successfully achieved compliance with Validation Master Plan for San Diego Plant for CAPA action through validation and documentation of equipment in the listed IOQP & IOQR.
- Performed thorough review of BARD products' Master Gap Assessment to meet MDR requirements for Labels and IFU.
- Ensured compliance of Labels, IFUS, Packaging Drawings and specifications of BARD products with EU-MDR redline regulations.
- Provided guidance to the team for successful launch of CR and InfoCard projects. Ensured packaging drawings comply with regulatory requirements.
- Reviewed customer feedback and complaints to identify quality issues and improvement opportunities.
- Finished projects on time and within budget.
- Trained personnel on the use of various quality control tools such as Statistical Process Control charts, Process Flow Diagrams, Failure Mode Effects Analysis.
- Prepared detailed reports outlining findings from investigations into customer complaints or other sources of information.
Education
Bachelor of Arts - Computer Applications
SASTRA DEEMED UNIVERSITY
Thanjavur, Tamil Nadu09-2023
Tech-bee - Diploma in Mech Automation
SSN School of Advanced Career Education, SNU
Chennai, Tamil Nadu11-2019
Skills
- Knowledge and Experience in ISO 9001, ISO 13485, ISO 14971, ISO 15223 and EUMDR
- CAD Tools: Basics of Solid works, Creo, and AutoCAD
- PLM Tools: SAP and Master Control
- Change Management and Complaint Management tool: PEGA and TrackWise
- MS office suite (Excel, Word, and PowerPoint)
- Technical Writing
- Team Leadership and Relationship Building
Certification
- ISO 13485 Internal Auditor – Certificate
Accomplishments
ERS Champions award - Knowledge Champion
Languages
Tamil
First Language
English
Upper Intermediate (B2)
B2
Hindi
Beginner (A1)
A1
Timeline
Quality Engineer
HCL Technologies
07.2019 - Current
Bachelor of Arts - Computer Applications
SASTRA DEEMED UNIVERSITY
Tech-bee - Diploma in Mech Automation
SSN School of Advanced Career Education, SNU
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