Summary
Overview
Work History
Education
Skills
Timeline
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Snehith Gadde

Woburn,MA

Summary

Results-driven Quality Engineer with 4 years of experience in the medical device manufacturing sector, specializing in quality assurance, regulatory compliance, and continuous process improvement. Proficient in ISO 13485 and FDA 21 CFR Part 820 standards, with a strong focus on process validation (IQ, OQ, PQ), risk management, and the implementation of corrective and preventive actions (CAPA). Demonstrated success in leading cross-functional teams, managing audits, and ensuring the highest standards of product quality to meet regulatory requirements and enhance patient safety.

Overview

4
4
years of professional experience

Work History

Manufacturing Quality Engineer

Becton Dickinson
Bengaluru, Karnataka.
07.2020 - 07.2022
  • Bought onboard to support the remediation of the CAPA process and the conversion of the paper-based CAPA process to EtQ.
  • Worked with the Project Manager to identify timelines for the EtQ upgrade.
  • Created a checklist to gather all paper documents and performed a thorough review of all documents tied to legacy CAPAs.
  • Led a cross-functional review of the final list of all CAPA documents and developed a protocol for the migration.
  • Reduced receiving non-conformances from over 100 to under 25 within the first three months by working overtime and scheduling dedicated working sessions with responsible owners.
  • Assigned as the owner for multiple CAPAs in different phases; planned, executed, and closed all assigned corrective actions effectively and on time.
  • Worked with the supplier to identify required CAPA fields and supported the customization of the tool for production deployment.
  • Reviewed and approved change orders related to product drawings, updates to SOPs, and other risk management files to address compliance gaps.
  • Conducted a gap analysis on the execution of the CAPA SOP for the paper-based process to feed the assessment results into the EtQ migration project.
  • Supported audits, both internal and external, by pulling requested documents and reviewing them prior to presenting them to the auditor.
  • Supported receiving inspection on conformances and disposition of the product.
  • Performed batch release in SAP as part of the QA review process, following the batch release SOP.
  • Reviewed and approved validation protocols and reports.
  • Conducted product engineering testing on returned products from complaints.
  • Prepared audit checklists with the help of the Quality Manager and led instructor-led training for cross-functional teams that included Manufacturing, Supplier Quality, Regulatory Affairs, Sterilization, and Purchasing.

Process Engineer

Stryker India Pvt .Ltd
Chennai, Tamilnadu
07.2018 - 07.2020
  • Collaborate with cross-functional teams to design and optimize manufacturing processes for medical devices, resulting in increased efficiency.
  • Assist in the implementation of Lean Manufacturing principles to minimize waste and improve production flow.
  • Support the development and maintenance of Standard Operating Procedures (SOPs) and work instructions, ensuring compliance with ISO 13485 and FDA regulations.
  • Conduct root cause analysis for production issues, implementing corrective and preventive actions (CAPA) to enhance product quality and reliability.
  • Facilitate training sessions for production staff on new processes and equipment, fostering a culture of safety and compliance.
  • Analyze production data to identify trends and areas for improvement, contributing to strategic decision-making processes.

Education

Master of Science - Data Science

New England College
Henniker, NH
05-2024

Bachelor of Science - Mechanical Engineering

J.N.T University
Hyderabad
05-2018

Skills

  • Six Sigma Methodologies
  • ISO 13485: Medical Device Quality Management Systems
  • FDA 21 CFR Part 820: Quality System Regulation (QSR)
  • Risk Management (ISO 14971)
  • Process Validation (IQ, OQ, PQ)
  • Statistical Process Control (SPC)
  • Failure Mode and Effects Analysis (FMEA)
  • Corrective and Preventive Actions (CAPA)
  • Supplier Corrective Action Request (SCAR)
  • Root Cause Analysis (5 Whys, Fishbone Diagram)
  • Good Documentation Practices (GDP)
  • Supplier Quality Management
  • Data Analysis & Reporting
  • Internal and External Auditing
  • Design of Experiments (DOE)
  • SAP EtQ Veeva Vault Trackwise
  • Microsoft Office 365 Certified

Timeline

Manufacturing Quality Engineer

Becton Dickinson
07.2020 - 07.2022

Process Engineer

Stryker India Pvt .Ltd
07.2018 - 07.2020

Master of Science - Data Science

New England College

Bachelor of Science - Mechanical Engineering

J.N.T University

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Snehith Gadde