Summary
Overview
Work History
Education
Skills
Timeline
Generic

Jeyaramkumar Rajendran

Bengaluru

Summary

With 12+ years of experience in Quality Assurance, I drive operational excellence through advanced automation and strategic leadership. As a Service Quality Assurance and Automation Lead at DePuy, I spearhead a team of 10 associates, leveraging Robotic Process Automation (RPA) to streamline tasks. This has resulted in a 30% reduction in manual work and a 25% increase in investigation accuracy.

Expert in automating dashboard creation and KPI tracking using Tableau and Power BI. Delivers actionable insights to drive continuous improvement initiatives. Skilled in mitigating quality risks, ensuring ISO standard adherence, and leading training programs for enhanced team performance

Overview

12
12
years of professional experience

Work History

Service Quality Assurance and Automation Lead

DePuy
04.2019 - Current
  • Lead a team of 10 associates to provide QA, compliance and QMS, KPI activities for Medical Devices as per ISO 13485, 21 CFR, EU MDR, IEC62304 and Client SOPs
  • Deploy Robotic Process Automation (RPA) to streamline repetitive testing tasks, ensuring consistent, accurate results, improving overall process efficiency and reducing 30% of manual work
  • Automate the creation of dashboards and reports using Tableau and Power BI to track KPIs, define action plans, and drive continuous improvement in KPI performance
  • Identify and escalate new or unknown risks related to quality issues in accordance with ISO 14971:2019, ensuring timely resolution
  • To Identify risks and escalate them to the department head and relevant functional heads
  • Performance improvement and interacting with users and training departments
  • Identification of repeat and overdue QMS events and ensure proper CAPA is in place to stop such Quality issues
  • Responsible for Projects reporting, Analysis of trends, Root Cause analysis, identification of process Corrective Actions and Preventive Actions in a weekly, monthly and Quarterly manner
  • Support and guide the teams for internal audits, external audits, customer audits
  • Review all Protocols and other closure reports and ensure they comply to regulatory audits
  • Own CAPA, NCs
  • Change Management for SOPs across Worldwide service centres
  • Monitor all quality issues that is identified to track them is all are closed on time.
  • Provided technical guidance to the development team on best practices related to automation.
  • Ensured that automation objectives are met in accordance with established standards.
  • Monitored system performance and identified opportunities for improvement.

Module Lead

Depuy Synthes
08.2018 - 03.2019
  • Provided strategic leadership to a global team, implementing automation tools to standardize and expedite the complaint processing workflow
  • This initiative resulted in a 30% reduction in processing time and a 25% increase in investigation accuracy
  • Led continuous improvement initiatives by designing and deploying automated complaint handling procedures
  • Enhanced process efficiency, which improved compliance rates by 20% and ensured consistency across global operations
  • Oversaw project deliverables with a focus on integrating automated tracking systems
  • Prepared Weekly Activities Trackers for clients using automated data aggregation tools, ensuring timely and accurate reporting aligned with business requirements
  • Collaborated with the Field Service Engineering, manufacturing, international and other departments to ensure complaint investigations are complete, thorough, timely and meet regulatory reporting requirements
  • Implemented automated systems for monitoring complaint trends and triggering the Company Issue Escalation Process
  • This proactive approach led to a 20% increase in issue resolution speed and a more efficient CAPA initiation process
  • Managed project deliverables by leveraging automated project management tools
  • Monitored, tracked, and coordinated team tasks to ensure error-free deliverables, achieving a 15% improvement in adherence to KPIs and Service Level Agreements (SLAs)
  • Applied automated compliance checking systems to review and approve investigations, ensuring adherence to FDA regulations and MDR reporting requirements
  • Conducted thorough investigations of adverse events, maintaining high standards of regulatory compliance and process integrity
  • Enhanced dashboards and performance metrics reports with automated data collection and visualization tools
  • Provided real-time insights and actionable updates to senior management, improving the visibility of key performance indicators (KPIs) and facilitating data-driven decision-making
  • Developed and coordinated comprehensive training programs that incorporated automated tracking and feedback systems
  • These systems enabled personalized developmental plans and streamlined skill assessments, boosting associate performance and engagement.

Customer Quality Analyst

Powertools
11.2014 - 08.2017
  • Expertise in complaint handling and post-market surveillance for medical products, ensuring regulatory compliance
  • Familiar with the Software Product Development Lifecycle, contributing to the development and enhancement of medical software products
  • Hands-on experience with complaint management tools like ETQ, Salesforce, TrackWise, facilitating efficient tracking and resolution of complaints
  • Proven ability to collaborate effectively with diverse teams, including engineers, scientists, clinical specialists, field service & application engineers, and manufacturing personnel
  • Strong communication skills for interacting with complainants, following up on complaints, and engaging with end users/customers through complaint submitters.

Design Engineer

06.2012 - 10.2014
  • 3D bone modeling, Designing and Segmentation for knee joints
  • Quality checking for through different phases of product design for patient specific instruments (PSI): CT acquisition, Image Segmentation and Designing.

Education

Bachelor’s Degree - Mechanical Engineering

Thiagarajar College of Engineering
04-2012

Skills

  • Quality Assurance & Regulatory Compliance
  • Expertise in CAPA, change control, audit management, and regulatory submissions
  • Medical Device Reporting
  • Proficient in electronic MedWatch 3500A reporting, EU MDR, and vigilance reporting (MEDDEV) in compliance with 21 CFR Part 803
  • Risk Management
  • Strong background in risk assessment, root cause analysis (RCA), and gap analysis; skilled in ISO 14971:2019 standards
  • Documentation and Training
  • Experience in preparing SOPs and work instructions (WIs); adept in LMS training assignments
  • Project Management
  • Proven ability in project management with a focus on quality assurance processes
  • Device History Review
  • Competent in device history record review and trend analysis
  • Verification and Validation
  • Knowledgeable in the verification and validation of instruments and software
  • Standards Known
  • Familiar with ISO 13485:2016, 21 CFR 820198, and IEC 62304

Timeline

Service Quality Assurance and Automation Lead

DePuy
04.2019 - Current

Module Lead

Depuy Synthes
08.2018 - 03.2019

Customer Quality Analyst

Powertools
11.2014 - 08.2017

Design Engineer

06.2012 - 10.2014

Bachelor’s Degree - Mechanical Engineering

Thiagarajar College of Engineering

Similar Profiles

CREATE PROFILE
Jeyaramkumar Rajendran