Summary
Overview
Work History
Education
Skills
Certification
Languages
Languages
Key Achievements
Timeline
Generic

Saravanaprakash K

Chennai

Summary

Experienced Quality Professional with 8 years in the mechanical and software industry, specializing in quality assurance, inspections, and team management. Proven track record inimplementing and managing quality

management systems (ISO9001,ISO 13485, AS9100, CMMI,ISO 14001,IATF16949 ), conducting audits, and driving supplier quality initiatives. Proficient in root cause analysis, cost of quality management, and coordinating quality improvement projects to achieve operational excellence , managing sub-contractors, and leading improvement initiatives. Holder of Lean Six Sigma Green Belt certification and proficient in Microsoft tools and Minitab.

Overview

8
8
years of professional experience
1
1
Certification

Work History

Senior Associate Executive

Infosys
Chennai
07.2024 - Current

Senior Executive QA

HCL Technologies
Chennai
08.2022 - 07.2024
  • Responsible for establishing policies, procedures of the organization according to ISO 9001, AS 9100,ISO 27001, ISO 13485 , FDA & CMMI requirements and other statutory and regulatory requirements
  • Organize external audits for certification, Re certification and surveillance audits for standard requirements.
  • Coordinate internal audits from audit plan to NC closure and analysis of the effectiveness of the corrective actions
  • Responsible for ensuring project plans provided are in compliance with the requirements of the Quality management system, Customer & Contractual requirements
  • Creation & Maintenance of corporate quality, program management, technical training records and ensure the compliance with customer specific trainings.
  • Creation & Representation of management dashboards, report for project status & key performance indicators of team performance
  • Ensure on time delivery for every quarter and analysis of customer specific data and customer satisfaction index periodically.
  • Prepare reports, graphs&presentation to track and take action to address the customer specific issues and perform gap analysis
  • Conduct work product reviews and process assessment on regular basis to keep the project on track with standard
  • Collaborated with cross-functional teams to resolve regulatory and quality-related issues during audits.
  • Prepared and submitted FDA 510(k) premarket notifications for Class II devices, achieving timely clearances.

Executive- QA/ RA

Medihub Sciencetech pvt ltd
12.2021 - 07.2022
  • Updating Technical Construction files, Design History Files (DHF), QMS document preparation, documentation & Design control
  • Preparing Quarterly trend reports for Management Review meeting with regards to product problems, complaint processing and MDRs.
  • Carrying out Supplier Audit at Supplier end and monitoring Supplier NC with Permanent & Corrective Actions.
  • Conducting internal audit in accordance with guidelines as per ISO Standards (13485:2016).
  • Manage Inspection & testing team for their productivity and effectiveness of inspection.
  • Conducting daily morning meeting with CFT team to take the actions of daily quality issues.
  • Ensure 5S on shop floor and lead for daily monitoring.
  • Reviewing risk management related files like risk management plan, risk management report as per ISO Standard (14971: 2019)
  • Developed and maintained regulatory dossiers for IMDR 2017 compliance, including device registration and licensing.
  • Assigned with responsibilities of Change control Management.
  • Experienced in assessment and analysis on Biocompatibility, Packaging, Stability,Sterilization, writing Protocols, performing testing's, etc., with respect to the country specific regulations for current configuration of the product.

Associate Executive - QA

PMI Global Technologies Pvt Ltd
04.2021 - 11.2021
  • Generation, monitoring and revising of Production part Approval Process (PPAP) documents for the child parts and products from the suppliers
  • Regular follow-ups on the supplier on action implementation & maintaining of the quality.
  • Responsible for Root Cause Analysis (RCA) of internal production line failures, customer complaints, 8D Action, MSA Study for Child Parts and Products
  • Liable for 8D Report preparation and interacting with Customers for Corrective and preventive actions
  • Participate in Actions (CAPA) implementation based on root cause analysis.
  • Managed supplier quality performance by conducting audits, ensuring compliance with quality standards, and implementing corrective actions.
  • Utilized inspection equipment such as CMM, VMM, and profile projectors,2d Height gauge for quality control and supplier alignment on testing requirements.
  • Developed and maintained performance metrics and data reporting for supply chain quality improvements.
  • Carrying out 5S, Poke- Yoke and kaizen activities for continuous improvement

Quality Engineer

Avalon Technology & Service Pvt Ltd
09.2018 - 01.2021
  • Preparing FAI Report as per AS9102B Formation standard .Order wise update COC report
  • Perform incoming, in process & final inspection as required
  • Performing inspections as per blueprints (GD&T), plans, and specifications to understand the requirements of products and services
  • Read Blueprint, specifications and quality plans to understand the requirements
  • Verify the COC and Test certificates and maintain of records against the GRN
  • Ensuring manufacturing processes like powder coating, plating, and machining to ensure adherence to quality standards.
  • Developed and implemented risk mitigation plans to address identified quality risks.
  • Partnered with cross-functional teams to deliver quality improvements, achieving measurable customer satisfaction
  • Establish action plan(s) and engage relevant departments in order to implement required improvement
  • Monitoring the effectiveness of given corrective action plans.
  • Managed internal and external Cost of Poor Quality (COPQ) metrics, leading targeted improvements.
  • Handled customer complaints, preparing and evaluating countermeasures using the 8D approach.
  • Involvement in FMEA, control plans and FAIR activities with quality engineering team

Quality Inspector

Autobhan Motor Products Pvt Ltd
09.2016 - 06.2018
  • Performing incoming inspection of raw materials and making report as per sampling plan
  • Responsible for maintaining Calibration of instruments& gauges
  • Responsible to first piece and last piece approval in line inspection for all components
  • Responsible for Final Inspection Stage (PDI) & Layout inspection

Education

B.E - Mechanical

G.K.M College of engineering and technology
05.2015

Skills

  • Statistical Process Control
  • Root Cause Analysis
  • Six Sigma
  • Failure Mode and Effects Analysis
  • Quality Management Systems
  • Lean Manufacturing
  • Process Improvement
  • Quality Auditing
  • Supplier Quality Management
  • Data analysis
  • PPAP,APQP,FMEA,SPC,MSA
  • 8D,RCA,7QC Tools
  • ISO 9001:2015
  • AS9100
  • ISO 13485
  • ISO 14001
  • ISO 27001
  • GD&T Y 145
  • CMMI
  • Minitab
  • Power BI
  • Risk Management
  • Problem-solving
  • Decision making
  • Predictive modeling
  • Regression analysis
  • Goals Setting
  • Trend Analysis
  • Internal Audits
  • Risk Analysis and Mitigation

Certification

Certified Six Sigma Green Belt

Languages

  • English
  • Tamil
  • Hindi

Languages

English
Advanced
C1
Tamil
Proficient
C2
Hindi
Intermediate
B1

Key Achievements

  • Successfully reduced the Cost of Poor Quality by 10% through targeted quality improvement projects.
  • Implemented comprehensive root cause analysis frameworks, improving corrective action closure rates by 20%.
  • Spearheaded ISO certification renewals with zero non-performance.

Timeline

Senior Associate Executive

Infosys
07.2024 - Current

Senior Executive QA

HCL Technologies
08.2022 - 07.2024

Executive- QA/ RA

Medihub Sciencetech pvt ltd
12.2021 - 07.2022

Associate Executive - QA

PMI Global Technologies Pvt Ltd
04.2021 - 11.2021

Quality Engineer

Avalon Technology & Service Pvt Ltd
09.2018 - 01.2021

Quality Inspector

Autobhan Motor Products Pvt Ltd
09.2016 - 06.2018

B.E - Mechanical

G.K.M College of engineering and technology

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