Yagnadeep Puttagunta
East Bridgewater,MA
Summary
Results-oriented Quality Engineer with 4 years of experience in medical device manufacturing, specializing in quality assurance, regulatory compliance, and process improvement. Expertise in ISO 13485, FDA 21 CFR Part 820, process validation (IQ, OQ, PQ), risk management, and corrective and preventive actions (CAPA). Proven ability to lead cross-functional teams, manage audits, and ensure the highest level of product quality.
Overview
4
4
years of professional experience
Work History
Quality Engineer
Phoenix Medical Systems (P) Ltd
Chennai, Tamilnadu
07.2020 - 07.2022
- Supported the development, implementation, and continuous improvement of quality control systems in compliance with ISO 13485.
- Conduct process validations (IQ, OQ, PQ) for new product lines, ensuring regulatory compliance and process efficiency.
- Lead risk management activities, including FMEA and control plan reviews, ensuring product safety and performance in accordance with ISO 14971.
- Conduct internal audits to assess the effectiveness of the Quality Management System (QMS) and support external audits with regulatory bodies (FDA, Notified Bodies).
- Implement Corrective and Preventive Actions (CAPA) to resolve non-conformances, customer complaints, and deviations, ensuring timely closure and effective root cause analysis.
- Collaborate with R&D and manufacturing teams to ensure seamless design transfer and adherence to quality standards during the development and production phases.
- Utilize Statistical Process Control (SPC) and other quality tools to monitor production processes, identify trends, and implement continuous improvements.
- Oversee supplier quality management, auditing suppliers, resolving non-conformance issues, and establishing quality agreements.
- Prepared and maintained Good Documentation Practices (GDP) to support the quality system, product development, and manufacturing activities.
Validation Engineer
Vimta Labs Limited
Hyderabad, Telangana
06.2018 - 06.2020
- Executed and documented validation protocols (IQ, OQ, PQ) for new and existing manufacturing equipment, utilities, and systems in compliance with industry standards and regulations (ISO 13485, FDA QSR).
- Coordinated cross-functional teams (Quality Assurance, Manufacturing, and Engineering) to ensure smooth and timely execution of validation activities.
- Managed the validation lifecycle, including the development of validation strategies, protocol preparation, execution, and final reporting.
- Conducted temperature mapping for controlled temperature units, stability chambers, autoclaves, and cold rooms to ensure equipment performance within specified limits.
- Provided support during regulatory audits, preparing validation documentation, and explaining the validation process to auditors.
- Investigated deviations, led root cause analysis, and implemented CAPA to ensure corrective and preventive actions were effective and compliant.
- Collaborated with QA teams to control and archive validation documents, ensuring that all processes met company and industry standards.
- Trained and mentored junior engineers and technicians on validation procedures and regulatory requirements.
- Participated in risk assessments, including Failure Mode Effects Analysis (FMEA), and worked to optimize equipment reliability and process efficiency.
Education
Master of Science - Mechanical Engineering
Oklahoma Christian University
Edmond, OK04-2024
Bachelor of Science - Mechanical Engineering
Jawaharlal Nehru Technological University
Kakinada 05-2018
Skills
- 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)
- Cross-Functional Team Collaboration
- Continuous Process Improvement
Timeline
Quality Engineer
Phoenix Medical Systems (P) Ltd
07.2020 - 07.2022
Validation Engineer
Vimta Labs Limited
06.2018 - 06.2020
Master of Science - Mechanical Engineering
Oklahoma Christian University
Bachelor of Science - Mechanical Engineering
Jawaharlal Nehru Technological University
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