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Oviyaasri Manimuthukumar

@oviyaasrimanimuthuku

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Detail-oriented Senior Quality Assurance Engineer with medical device expertise.

India

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What I'm looking for

I am looking for a role that fosters continuous improvement and innovation in quality assurance.

I am a Senior Quality Assurance Engineer with over four years of experience in the medical device industry. My expertise lies in manufacturing process optimization, quality control, and compliance, where I have successfully led cross-functional teams to drive continuous improvement initiatives. My proactive approach has ensured seamless adherence to quality standards, including ISO 13485 and FDA regulations.

At InverMed in Galway, I spearheaded defect reduction initiatives that decreased product failure rates by 70% through advanced root cause analysis techniques. I also developed and implemented in-line inspection protocols, resulting in a 40% reduction in non-conformities. My commitment to operational efficiency is further demonstrated through my management of supplier quality assurance processes and the successful development of a Kaizen app to optimize performance metrics.

My educational background includes a Master of Neuroscience from the National University of Ireland, Galway, and a Bachelor of Biotechnology from Bannari Amman Institute of Technology. I am passionate about leveraging my skills in statistical analysis and data visualization to enhance quality assurance processes and contribute to the advancement of medical device compliance.

Experience

Work history, roles, and key accomplishments

Senior Quality Assurance Engineer

InverMed

Jan 2023 - Jan 2024 (1 year)

Led production teams in optimizing manufacturing processes, achieving a 30% reduction in cycle time while ensuring compliance with ISO 13485 and FDA regulations. Spearheaded defect reduction initiatives, decreasing product failure rates by 70% through advanced root cause analysis techniques. Developed and implemented in-line inspection protocols, significantly improving first-pass yield.

Root Cause Analysis Data Analytics

Data Analytics Trainee

MedTour Easy

Oct 2023 - Dec 2023 (2 months)

Utilized Power BI and Excel to analyze defect trends and optimize manufacturing control strategies. Applied data visualization techniques to evaluate production KPIs, enhancing decision-making in quality control.

Data Analysis Power BI Excel Quality Control Data Visualization KPIs Process Optimization Statistical Analysis Defect Trending

Quality Specialist

Creganna Medical

Jun 2021 - Jan 2023 (1 year 7 months)

Implemented statistical process control methodologies, leading to a 30% reduction in process variability. Designed training programs for operators on GMP and CAPA, enhancing compliance awareness. Collaborated with production and engineering teams to improve throughput by 25% through lean initiatives.

Risk Analysis Quality Assurance Cross Functional Collaboration Compliance Process Improvement Root Cause Analysis

Quality Assurance Intern

VB Medicare Private Limited

Dec 2016 - Dec 2016 (0 months)

Gained hands-on experience in quality control methodologies, specializing in analytical techniques such as HPLC and GC analysis. Assisted in clinical trial testing and developed SOPs for regulatory compliance.

Quality Control GC Analysis Clinical Trials SOP Development Regulatory Compliance Statistical Data Analysis Quality Assurance Analytical Techniques

Education

Degrees, certifications, and relevant coursework

National University of Ireland, Galway

Master of Neuroscience, Neuroscience

2015 - 2019

Proficient in Master of Neuroscience, focusing on advanced studies in the field of neuroscience, including research methodologies and clinical applications.

Bannari Amman Institute of Technology

Bachelor of Biotechnology, Biotechnology

2015 - 2019

Grade: GPA: 8.0

Bachelor of Biotechnology program that provided a comprehensive understanding of biotechnological principles and practices, including laboratory techniques and bioprocessing.