Siva K
Bangalore
Summary
Detail-oriented and results-driven Quality Engineer with over 9 years of extensive experience in quality assurance, supplier quality management, and continuous improvement initiatives. Proficient in problem-solving methodologies, risk assessment, and regulatory compliance, with a track record of driving quality enhancements and reducing defects. Seeking a challenging position to leverage my expertise in quality management and contribute to organizational excellence.
Overview
8
8
years of professional experience
Work History
Supplier Quality Engineer
RGBSI
Bangalore
07.2021 - Current
- Led PPAP activities, ensuring timely and thorough document reviews and approvals.
- Conducted investigations on complaints using Trackwise, involving product identification, inspection, and comprehensive risk analysis.
- Applied 8D problem-solving methodology to resolve quality issues effectively.
- Developed and delivered customized product training presentations based on updated client non-conformance data.
- Created and managed FMEA documentation to ensure process reliability and compliance.
- Delivered approximately 700 PPAPs within a year, maintaining zero customer complaints.
Quality Engineer
GESCO Healthcare Pvt. Ltd.
Chennai
11.2018 - 06.2021
- Conducted quality assurance activities for implantable medical devices and surgical instruments, ensuring compliance with ISO 13485 standards.
- Performed rejection analysis and implemented control measures to reduce defects.
- Managed and resolved outsourced repair complaints by collaborating with cross-functional teams.
- Performed product inspections, document reviews, and risk assessments for quality and safety.
- Led root cause analysis and implemented CAPA for process improvements.
- Proficient in quality tools such as FMEA, 8D, and ISO 13485 standards.
Quality Engineer
SPICA Metfab Solutions Pvt. Ltd.
Chennai
10.2017 - 11.2018
- Supported new product development (NPD) initiatives while integrating quality standards.
- Raised and managed 8D requests for supplier nonconformances, adhering to strict timelines.
- Monitored quality processes, including incoming and line inspections, and resolved customer complaints.
- Demonstrated expertise in the powder coating process for quality consistency.
- Ensured effective documentation and management of the machine shop.
Quality Engineer
Maika Metals Pvt. Ltd.
Chennai
08.2016 - 10.2017
- Managed incoming inspections, line inspections, and customer complaints to ensure product quality.
- Implemented rejection reduction strategies using Pareto analysis.
- Supervised powder coating processes and assembly lines for quality assurance.
- Conducted inspections of CNC, punching, and bending machines to ensure accuracy.
- Maintained comprehensive documentation and record-keeping to support operations.
Education
Bachelor of Engineering - Mechanical Engineering
JJ College of Engg & Technology
Thiruchirapalli04-2015
Skills
- Quality Tools and Methodologies:
- 8D Problem-Solving
- FMEA (Failure Modes and Effects Analysis)
- CAPA (Corrective and Preventive Actions)
- PPAP (Production Part Approval Process)
- APQP (Advanced Product Quality Planning)
- Risk Assessment and Management
- Standards and compliance
- ISO 13485:2016 (Medical Devices – Quality Management Systems)
- ISO 9001:2015 (Quality Management Systems)
- VDA 63
- Other Skills
- MSA & SPC
- Rejection analysis and root cause analysis
- Supplier Performance Evaluation
- Trackwise (Complaint Management System)
- Strong cross-functional collaboration
- Effective Communication and Reporting
- Supplier Quality Management
- Continuous Improvement Initiatives
- Regulatory Compliance and Auditing
Timeline
Supplier Quality Engineer
RGBSI
07.2021 - Current
Quality Engineer
GESCO Healthcare Pvt. Ltd.
11.2018 - 06.2021
Quality Engineer
SPICA Metfab Solutions Pvt. Ltd.
10.2017 - 11.2018
Quality Engineer
Maika Metals Pvt. Ltd.
08.2016 - 10.2017
Bachelor of Engineering - Mechanical Engineering
JJ College of Engg & Technology
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