RAMKUMAR K
Tenkasi
Summary
A passionate Quality Engineer in Medical Device & Automobile Industry with experience in design controls, risk management, quality engineering and FDA, ISO and EUMDR regulations. Applied appropriate design controls, lean manufacturing concepts, quality assurance techniques and methodologies to improve quality and efficiency of products manufacturing.
Overview
7
7
years of professional experience
Work History
Lead Engineer
HCL Technologies
Madurai
06.2021 - Current
- Design change control activities for DePuy Synthes as Design Quality Engineer.
- Direct Part Marking implementation of EU MDR requirements in medical devices.
- Authored and managed Design Change Evaluation documents.
- Reviewed product drawings update through all stages for design changes and to ensure it meets GD&T standards.
- Reviewed and Approved risk management documents, Product Quality Plans revisions.
- Managed Good Documentation Practices to be followed across the project.
- Change Approver task in Windchill and Agile PLM system.
- Lead Design Review meetings and Design Assessment Meetings and managed and documented the same for Design History Files.
- Additionally supported in Defect Preventive Analysis (DPA) and CMMI (High Maturity) activities.
Project Quality In-charge
Omnex Quality Academy India Pvt. Ltd.
Chennai
04.2019 - 09.2020
- Participate on Product Development projects and PPAP document creation(Layout Inspection, FMEA, Control Plan, Product Checklist).
- Participate on Design & Process improvement activities with CFT team for existing projects.
- Inspect and Analyze the products as per layout checklist and correct them in design or process level if the parameters are getting deviate.
- Analyze the customer complaint in process line and close them by CAPA.
- Assigning tasks to Inspectors in process line.
Quality Engineer
Castwel Auto Parts Pvt. Ltd.
Chennai
11.2017 - 03.2019
- Prepare product and process checklist for new products.
- Assisted and Prepared G8D, PDCA & Corrective action plan report for customer complaints.
- Ensure product and process specifications by Quality inspection method.
- Briefing the daily quality status to manufacturing team and management.
- Reducing process major defects by supporting CFT team through problem solving tools like Why-Why analysis and Fish bone method.
Graduate Apprentice Trainee
Rane Madras Ltd.
Chennai
11.2016 - 11.2017
- Ensure 100% compliance to be control plan for all the manufacturing line.
- Performed quality inspections and drafted reports to detail non-conforming material issues.
- Improve the 5S activities in process line and maintain the same for the month.
- Supported quality team members during corrective action updates.
- Contributed to root cause analysis to determine core reason for failures and errors.
Education
Bachelor of Engineering - Mechanical Engineering
Jaya Sakthi Engineering College
Chennai, India04-2016
Skills
- Quality Assurance
- Design Control
- Problem Solving Techniques
- Manufacturing Process
- Product Development
- Project Management(DPA,CMMI)
- MS Office
- Windchill & Agile PLM
- JDE ERP System
- CREO Parametric
Manufacturing Instrument Handling
- Vernier, Micrometer
- Profile Projector, VMM
- 2D Height Gauge, Dial Height Gauge
Timeline
Lead Engineer
HCL Technologies
06.2021 - Current
Project Quality In-charge
Omnex Quality Academy India Pvt. Ltd.
04.2019 - 09.2020
Quality Engineer
Castwel Auto Parts Pvt. Ltd.
11.2017 - 03.2019
Graduate Apprentice Trainee
Rane Madras Ltd.
11.2016 - 11.2017
Bachelor of Engineering - Mechanical Engineering
Jaya Sakthi Engineering College
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