Sarath Kumar
Engineer
Chennai
Summary
Dedicated, proactive, and well-organized Quality Engineer with 11 Years experience in the QC and Medical Device Manufacturing Fields and Standards. Having a good knowledge of Post Market Surveillance Activities. Strong background in every area of quality control and quality improvement professions. Seeking assignments in Quality Assurance, Quality Control, Engineering Guidance and Production planning with a growth-oriented organization. Hands on experience in Supplier Development Processes like Production Part Approval Process and Supplier Evaluation and Supplier Audits.
Overview
11
11
years of professional experience
6
6
years of post-secondary education
1
1
Language
Work History
Senior Analyst
HCL Technologies
Chennai
02.2021 - Current
- Handling Post Market Surveillance Activities for Products (Infusion Pumps, Sports Medicine, Power Tools)
- Managing 500-1000 complaints per month approximately with 4-5 size of Team
- Experienced in Medical Device reporting through Track Wise & ECM Configure with SAP & Salesforce
- Investigate complaints and adverse events thoroughly to determine the root cause and any contributing factors. This may involve collaborating with cross-functional teams such as R&D, manufacturing, quality assurance, and regulatory affairs.
- Prepare and submit regulatory reports as required by applicable regulations, such as Medical Device Reporting (MDR) to FDA, Vigilance Reporting to Competent Authorities in EU, and other regulatory agencies worldwide.
- Identify opportunities for process improvements within post-market surveillance function to enhance efficiency, effectiveness, and compliance.
- Support internal audits and regulatory inspections by providing documentation, data, and other information related to post-market surveillance activities.
- Collaborate with cross-functional teams, including regulatory affairs, clinical affairs, quality assurance, and product development, to ensure alignment and integration of post-market surveillance activities with other business processes.
Quality Engineer
Neomotion Assistive Solutions
Chennai
03.2020 - 02.2021
- Interacted with Modular Designed Wheelchair Products Neo Bolt & Neo Fly.
- Monitor entire production cycle and perform regular tests to identify potential malfunctions as early as possible
- Inspect product materials and electrical systems for defects and durability.
- Identify root of technical issues and recommend fixes.
- Prepare reports on malfunctions and corrective actions.
- Select output samples and check them using appropriate methods (measuring dimensions, testing functionality, comparing to specifications, etc.) Approve or reject raw materials with respect to quality standards and record supplier performance
- Report all malfunctions to production executives to ensure immediate action
Junior Engineer - Quality
CURA Healthcare
07.2015 - 06.2019
- Hands on experience with Imaging Devices ( X-Ray, Ultrasound, C-Arm)
- Interpret specifications, blueprints, job orders, and company policies & procedures for workers.
- Read and analyze charts, work orders, production schedules and to evaluate current production estimates and outputs. Conduct audits of supplier quality system and approve new suppliers along with verifying ongoing supplier performance.
- Identify root cause and respond with corrective action.
- Participated in development of Failure Mode and Effects Analysis (FMEA).
- Participated in Advanced Product Quality Planning activities to determine appropriate use of existing and new measurement systems during new tool or process design and startup.
Diploma Engineer
Delphi - TVS
01.2013 - 04.2015
- Performed as Diploma Engineer in Production line
- Experienced with Computer Numerical Machines and Conventional Machines
- Maintain operation data such as production and cost records
- Recommend measures to improve production methods, equipment performance, product quality
- Setup and adjustment machines & Evaluate Overall Effective Efficiency(OEE)
Education
Bachelor of Engineering / Bachelor of Technology - Mechanical
Meenakshi Academy of Higher Education And Research
CHENNAI, Tamil Nadu 11.2015 - 04.2019
Diploma - Mechanical
Murugappa Polytechnic College
CHENNAI, Tamil Nadu 06.2009 - 04.2012
Skills
510K
Knowledge of Medical Device Standards ISO 13485:2016Product Life Cycle Management ActivitiesIEC 62304
Failure Analysis
ISO13485
ISO14971
CAPA
Risk Management
FMEA
Personal Information
- Passport Number: T0747136
- Date of Birth: 12/10/1993
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Disclaimer
I, Sarath Kumar, hereby declare that the information contained herein is true and correct to the best of my knowledge and belief.
Timeline
Senior Analyst
HCL Technologies
02.2021 - Current
Quality Engineer
Neomotion Assistive Solutions
03.2020 - 02.2021
Bachelor of Engineering / Bachelor of Technology - Mechanical
Meenakshi Academy of Higher Education And Research
11.2015 - 04.2019
Junior Engineer - Quality
CURA Healthcare
07.2015 - 06.2019
Diploma Engineer
Delphi - TVS
01.2013 - 04.2015
Diploma - Mechanical
Murugappa Polytechnic College
06.2009 - 04.2012