Summary
Overview
Work History
Education
Skills
Timeline
Generic

Aasish Chand Chodagiri

Quality Engineer

Summary

Engineering professional with extensive experience in the medical device and pharmaceutical industries, focusing in Manufacturing Quality Engineering, Process Validation, and Quality Systems Control. Proven track record of driving process improvements, maintaining regulatory compliance, and implementing strong quality control measures to support successful new product introduction (NPI) and development (NPD).

Overview

7
7
years of professional experience

Work History

Quality Engineer

ICU Medical
05.2024 - Current
  • Led engineering studies and process validations, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), to ensure compliance with ISO 13485, FDA standards, and EU MDR.
  • Led the creation and implementation of Test Method Validations (TMV) for a variety of tests, assuring high accuracy in analytical, attribute, and variable measurements.
  • Conducted gauge R&R studies and revised fixtures to improve measurement accuracy and process efficiency, hence contributing to overall process optimization.
  • Operators received extensive training on new operational work instructions, standard operating procedures (SOPs), and test methods, ensuring that quality standards were consistently met on the production floor.
  • Actively participated in troubleshooting sessions to address manufacturing quality issues, resulting in the production of compliant and safe medical equipment.
  • Collaborated with suppliers to increase product quality, save prices, and streamline logistics, resulting in a more efficient and dependable supply chain.
  • Contributed to new product development (NPD) and new product introduction (NPI) by creating, validating, and optimizing product concepts, resulting in successful product launches and effective market entry.
  • Implemented stringent quality control methods, such as inspections and testing protocols, to assure compliance with ASME and other regulatory standards, hence protecting product safety and reliability.
  • Developed and carried out project plans to address high-priority Corrective and Preventive Actions (CAPAs), including frequent meetings to track and drive progress.
  • Technical files were thoroughly examined and updated to reflect changes in supplier information, manufacturing procedures, cleaning, packaging, and labeling, ensuring comprehensive and accurate documentation.
  • Conducted a thorough gap analysis and revised technical manufacturing documents to meet the most recent quality requirements, enabling seamless regulatory compliance.
  • Collaborated closely with suppliers and internal teams to quickly address and resolve production difficulties, guaranteeing continuous production and high-quality output.
  • Collaborated with the supplier's quality engineer to create and edit technical files, ensuring they satisfied strict quality and regulatory requirements.
  • Used Six Sigma, DMAIC, and other statistical methods to assess and improve manufacturing processes, resulting in higher product quality and efficiency.
  • Ensured continued compliance with ISO 13485 and FDA regulations throughout the product development and manufacturing processes, while upholding the highest quality standards.
  • Implemented ISO 14971 risk management concepts to achieve thorough risk assessment and mitigation in manufacturing operations.
  • Root cause analyses (RCA) were conducted utilizing 8D, 5 Whys, and fishbone diagrams, which effectively addressed and reduced product defects by 15%.
  • Managed Windchill's change control processes, including document revisions, approvals, and smooth document control activities.
  • Gap assessments were performed on master validation reports, and data from the quality team was updated, including build traceability, sample selection, and validation processes.
  • Updated and maintained risk management files (FMEA), control plans, and process capability studies to enable continuous process design and operational qualification.
  • Worked with the regulatory and supplier teams to update and monitor Quality Management System (QMS) papers and manufacturing IT systems.

Quality Engineer

Seraph biosciences inc
06.2023 - 05.2024
  • Maintained production paperwork, such as production Work Instructions, SOPs, Change Control paperwork, NCRs, and CAPAs, in accordance with FDA 21 CFR Part 820 and ISO 13485.
  • Followed the FMEA process standards and internal procedures/requirements.
  • Created test methodologies and protocols, validated them as needed, and conducted and recorded such tests in reports.
  • Created manufacturing instructions, inspection procedures, testing protocols, assembly drawings, equipment control paperwork, and component drawings.
  • Designed and improved manufacturing processes utilizing DMAIC and A3 techniques for effective production layouts and equipment installation in accordance with Lean Manufacturing principles and ISO 9001.
  • Identified and resolved technical and quality concerns; took part in MRB, customer complaint investigations, CAPA activities, design efforts, and regulatory filings.
  • Coordinated troubleshooting to quickly address production issues, minimize downtime, and keep production schedules.
  • Use Statistical Process Control (SPC) approaches to monitor and enhance process capabilities and product quality.
  • Managed a team to create PFMEA and Control Plan papers from scratch by individually observing, learning, and reviewing manufacturing processes.
  • Correlation and regression analysis, experimental design (DOE), and acceptability sampling were all carried out, as well as Gauge R&R studies.
  • Developed IQ/OQ/PQ methods, tested products and manufacturing equipment, and prepared reports for process validation.
  • Implemented PPAP and PPAQ processes to verify all components and materials met quality standards prior to full-scale manufacturing, which included document preparation, auditing, and engaging with suppliers.
  • Risk assessments were performed in accordance with ISO 14971 to identify and reduce hazards in production processes.
  • Continued to work directly with assemblers and production teams to streamline manufacturing processes and ensure high-quality output.
  • Implemented floor-level adjustments based on direct observations, resulting in a more efficient and collaborative workplace.
  • Supported manufacturing fields' requirements for quality standards and compliant documentation, capacity, product availability, and pricing.
  • GAP analysis was performed, remediation plans were written, and a requirement traceability matrix was constructed.

Manufacturing Quality Engineer

Neuland laboratories limited
12.2020 - 06.2022
  • Provided technical support for Corrective and Preventive Action (CAPA) investigations, including root cause analysis and corrective measure execution, to ensure prompt closure and compliance with pharmaceutical standards.
  • Managed and executed PPAP and PPAQ processes to guarantee that components and materials met high quality standards prior to mass production, resulting in successful product launches and consistent quality outcomes.
  • Developed and carried out validation protocols (IQ, OQ, and PQ) for new manufacturing processes and equipment while conforming to cGMPs, Annex 15, and other pharmaceutical requirements.
  • Gap analysis and remediation of technical files were performed to guarantee compliance with 21 CFR Part 210, 211, and ICH principles, with a focus on data integrity and regulatory adherence.
  • Collaborated with cross-functional teams to handle technical and quality concerns, managing MRB meetings and taking part in Reject Material Authorization (RMA) sessions.
  • Managed the creation and approval of computer system validation (CSV) deliverables such as validation plans, risk assessments, and compliance with 21 CFR Part 11.
  • Value Stream Mapping was created for manufacturing cells, minimizing repetitive actions and increasing workflow efficiency in pharmaceutical production.
  • Review and verify SOPs, Batch Reports, and other essential documents to ensure compliance with regulatory standards and quality assurance methods.
  • Assisted with MES implementation, including the creation of user requirements, test scripts, and validation protocols for factory execution systems.
  • Supported regulatory teams by evaluating and completing functional evaluation questionnaires, resulting in complete documentation for regulatory filings.
  • Test Method Validation (TMV) was carried out by examining DFMEAs and maintaining a Requirements Traceability Matrix (RTM) to ensure that validation operations were thoroughly documented.
  • Technical support was provided for the validation of process systems, such as fermenters, filtration units, and biochemical reactors, to ensure that production processes were robust.
  • Coordinated CAPA efforts, created mitigation strategies to resolve noncompliance issues, and ensured compliance with 21 CFR Part 11 and EU Annex 11 regulations.

Quality Engineer

Shilpa medicare ltd
01.2019 - 07.2019
  • Assisted in developing and implementing IQ/OQ protocols and reports to validate lab testing equipment, assuring ISO 13485 and GMP compliance.
  • Worked on work orders, preventive maintenance, corrective action requests (CARs), SOPs, CAPAs, Change Controls, and GMP in the packing department.
  • Supported the implementation of Total Quality Management and Continuous Improvement initiatives, with an emphasis on improving supplier performance and the packaging process.
  • Contributed to the packaging engineering department by evaluating novel packaging concepts and validating designs using rigorous testing procedures.
  • Executed protocols and Master Batch Records were reviewed, changed, and audited to ensure accuracy and compliance with quality requirements.
  • To ensure quality compliance, we prepared protocol exceptions, process deviations, and supported investigations for non-conformances (NCs) and CAPAs.
  • Collaborated with the QA, R&D, and Manufacturing teams to optimize processes, save money, and introduce new products while ensuring quality objectives were fulfilled.
  • Applied GD&T and Design for Manufacturability principles to determine manufacturing feasibility, hence improving quality and compliance.
  • Design of Experiments (DOE) were conducted using Minitab to examine process parameters, and statistical methods were used to assure process accuracy.

Education

Master of Science - Automotive Engineering

Lawrence Technological University
12.2024

Bachelor of Technology - Mechanical Engineering

Koneru Lakshmaiah Education Foundation
05.2021

Skills

  • Validation: Capable of creating and carrying out Test Method Validation (TMV) and validation protocols (IQ, OQ, and PQ) in accordance with ISO 13485, FDA rules, EU MDR, and pharmaceutical standards, such as cGMP and 21 CFR Part 210/211
  • Statistical Analysis: Able to use Minitab for comprehensive statistical analysis, such as regression analysis, Design of Experiments (DOE), and Gauge R&R studies to improve process quality in pharmaceutical and medical device manufacturing
  • Quality Assurance: In order to surpass industry norms, quality assurance requires proficiency in gap analysis, technical file cleanup, and the use of GMP, GDP, and ISO 9001 procedures
  • Delivery Systems: Practical expertise with delivery systems, guaranteeing adherence to strict quality standards and maximizing their functionality by thorough testing and validation
  • CAD & SolidWorks: Proficient in using CAD software, including SolidWorks, to optimize engineering designs and validate innovative packaging and product concepts during NPD and NPI initiatives
  • Lean manufacturing: Proficient in using Lean Six Sigma approaches like DMAIC and root cause analysis (8D, 5 Whys) to drive continuous improvement and reduce errors in medical device and pharmaceutical manufacture
  • Collaboration: Proven ability to work with suppliers, regulatory teams, and internal production teams to overcome obstacles and achieve success in NPI and NPD projects
  • Documentation and Change Management: Proficient in managing and updating essential manufacturing documents such as SOPs and FMEAs, as well as using Windchill for efficient document control
  • Process Optimization: Specializing in assessing and improving manufacturing processes in the medical device and pharmaceutical industries using capability studies, process flow diagrams, and other optimization methodologies
  • PPAP and PPAQ: Implemented and managed PPAP and PPAQ procedures, ensuring that components and materials met quality standards prior to full-scale manufacturing, which included document preparation, auditing, and supplier collaboration
  • Risk Management: Proficient in using ISO 14971 risk management concepts to identify, assess, and reduce risks in medical device development and production processes

Timeline

Quality Engineer

ICU Medical
05.2024 - Current

Quality Engineer

Seraph biosciences inc
06.2023 - 05.2024

Manufacturing Quality Engineer

Neuland laboratories limited
12.2020 - 06.2022

Quality Engineer

Shilpa medicare ltd
01.2019 - 07.2019

Bachelor of Technology - Mechanical Engineering

Koneru Lakshmaiah Education Foundation

Master of Science - Automotive Engineering

Lawrence Technological University

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Aasish Chand Chodagiri