Open to opportunities

Girija YC

@girijayc

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Experienced Medical Device Professional with a focus on quality and compliance.

India

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What I'm looking for

I am looking for a role that allows me to leverage my extensive experience in quality management and regulatory compliance within the medical device industry, while also providing opportunities for professional growth and leadership.

I am a dedicated Medical Device Professional with 17 years of experience in Quality Control (QC), Quality Assurance (QA), and Regulatory Affairs (RA). My career has been marked by a commitment to delivering outstanding quality and service, which has earned me recognition for my performance in various roles. Currently, I serve as a Tech Lead at L&T Technology Services, where I drive Supplier Quality Audits and manage quality agreements, ensuring compliance with industry standards.

Throughout my career, I have held significant positions, including Deputy Manager at Essilor India and Client Manager at BSI India. My expertise spans across Supplier Quality Management, QMS Auditing, and Microbiology, with a strong focus on regulatory compliance in the Asia, Middle East, Russia, and Africa regions. I have successfully implemented Quality Management Systems and conducted training on regulatory compliance, contributing to the overall improvement of quality standards in the medical device industry.

Experience

Work history, roles, and key accomplishments

Current

Tech Lead – Medical Devices

Current

L & T Technology Services

Jul 2021 - Present (3 years 11 months)

Leading Supplier Quality Audits and Quality agreements, preparing PPAP documents, and managing Supplier Quality Management activities. Involved in FDA 21CFR Part 820 updates and document retrieval for EUMDR.

Supplier Quality Audits Supplier Management 21 CFR 820 Quality Management Systems

Client Manager – Medical Devices

BSI India Private Limited

Mar 2018 - Jun 2021 (3 years 3 months)

Performed audits on clients' Quality Management Systems, focusing on ISO 9001 and ISO 13485 compliance. Managed internal audits and ensured quality system performance.

Quality Management Systems ISO 9001 ISO 13485 Internal Audit Regulatory Compliance Client Management Quality Assurance Quality Control

Deputy Manager – Quality & Regulatory

Essilor India Private Limited

Jul 2018 - Feb 2021 (2 years 7 months)

Created a Quality Management System for AMERA regions, focusing on regulatory compliance and training. Conducted audits on regulatory requirements and implemented QMS.

Quality Management Systems Regulatory Compliance ISO 13485 ISO 9001 Auditing Training

QC Manager & MR

Vascular Concepts Limited

May 2007 - Mar 2018 (10 years 10 months)

Managed quality control processes, prepared regulatory documentation, and conducted internal audits. Supervised microbiological tests and ensured compliance with ISO standards.

Quality Control Regulatory Internal Audit Microbiological Testing ISO 13485