K P JOB
Ernakulam
Summary
Results-driven Quality Engineer with over 5 years of experience, recognized for enhancing inspection efficiency by 15% through exceptional leadership and problem-solving capabilities. Proficient in regulatory compliance with ISO 13485 and FDA standards, dedicated to improving process reliability through thorough root cause analysis.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Quality Engineer
Inito
Bangalore
07.2021 - Current
- Led training sessions and provided coaching to junior inspectors, resulting in a 20% reduction in non-conformances and a 15% increase in inspection efficiency
- Managed and maintained compliance with ISO 13485, (EU) Medical Device Regulations 21CFR Part 820, and relevant Good Manufacturing Practice (GMP) regulations within the company's Quality Management System
- Established manufacturing quality metrics, KPIs, and calibration standards, effectively identifying and resolving issues, reporting losses, and driving continuous improvement initiatives
- Identified non-conformances(NCR) and initiated corrective actions and preventive actions(CAPA), verifying their effectiveness
- Worked closely with sales and technical support teams to investigate client issues thoroughly, trace root causes, and implement corrective actions, resulting in enhanced customer satisfaction and retention
- Spearheaded the integration of process control systems, ensuring consistent compliance with ISO 13485, which increased production accuracy by 18% over 12 months
- Conducted root cause analysis(RCA) on recurring quality defects using Six Sigma methodologies, resulting in a 30% reduction in defect rates over 6 months and enhanced process reliability
Quality Control Inspector
Karnataka Automats Pvt Ltd
Bangalore
08.2018 - 05.2021
- Consistently met quality control targets, achieving a 95% or higher rating every month and receiving recognition for exceptional performance
- Operated and managed a variety of precision measuring instruments including the Vision Measuring Machine (VMM), Digital Height Gauge, Profile Projector, and CMM
- Implemented and maintained standard operating procedures (SOPs) for Quality Control, ensuring strict adherence by production operators
- Conducted line clearance protocols daily, ensuring compliance with regulatory standards and reducing product defect rates by 10% using Vision Measuring Machine and CMM
- Verified compliance of manufactured products with design specifications, utilizing VMM and CMM to achieve a 98% accuracy rate over 12 months
- Spearheaded the implementation of continuous improvement tools such as Kaizen and PDCA cycles, achieving a 20% increase in inspection efficiency within 3 months by streamlining quality control workflows
Education
Bachelors in Engineering - Mechanical Engineering
Dr T Thimmaiah Institute of Technology
Banglore, Karnataka, India01.2014
High School Diploma - Computer Science
Santa Maria Senior Secondary School
Kochi, Kerala, India01.2013
Skills
- Regulatory compliance (eg ISO 9001, ISO 13485, FDA)
- Root cause identification
- PPAP submissions
- Corrective action and problem-solving skills
- Leadership abilities
- Teamwork skills
- Strong time management skills
- Keen attention to detail
- Analytical and problem solving abilities
- Proficiency in MS Office
- Effective communication skills
- Auditing and inspection skills
Certification
Certified Internal Auditor For Quality Management System Based on ISO 9001:2015
Timeline
Quality Engineer
Inito
07.2021 - Current
Quality Control Inspector
Karnataka Automats Pvt Ltd
08.2018 - 05.2021
Certified Internal Auditor For Quality Management System Based on ISO 9001:2015
Bachelors in Engineering - Mechanical Engineering
Dr T Thimmaiah Institute of Technology
High School Diploma - Computer Science
Santa Maria Senior Secondary School
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