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Quality Engineer Resume

Hercules, CA

SUMMARY

  • Experience in Software Quality Engineering and Process improvements in Pharmaceutical and Medical Devices industries.
  • Supported the design, development and deployment of Software applications used in Medical Systems.
  • Proficient in ISO 13485, ISO 14971, ISO 62304, CFR 820, CFR 803, CFR 11.
  • Performed Validation and Verification activities for the implementation of Software Systems in FDA regulated environments.
  • Excellent knowledge of full Software Development Life Cycle (SDLC).
  • Hands on experience in analyzing the business requirements and Functional and Design Specifications.
  • Developed test requirements and mapped them to business requirements.
  • Created traceability Matrices and regularly updated them.
  • Experience Reviewing, Authoring and Developing Validation deliverables including VMP, IQ/OQ/PQ, SOPs, VSR, Requirements Traceability Matrix (RTM).
  • Experience in performing GAP analysis and devising Remediation Plans.
  • Authored and Reviewed Test Strategy, Test Plan, Test Scripts, Defect Reports and Test Summary Reports.
  • Knowledge of Corrective and Preventive Action (CAPA) reporting, handling and closing, using Track wise.
  • Knowledge of Quality Systems Regulations (QSR), GMP, and ISO Regulations.
  • Exposure to all kinds of testing namely Smoke, Integration, Regression and Systems Integration testing.
  • Strong verbal and written communication, organization, problem solving and interpersonal skills.

PROFESSIONAL EXPERIENCE

Confidential, Hercules, CA

Quality Engineer

Responsibilities:

  • Review and Approval of project documents like Product Design Document (PDD), Risk Impact Assessment (RIA).
  • Review and approval of Test Runs and Script for UAT, Integration and Regression Testing for ongoing production support projects.
  • Communication with various SAP teams regarding Test coverage and Good Documentation practices and Part 11 compliance.
  • Review and approval of Test scripts for SAP Implementation Project for Requirement coverage.
  • Creation of Work Instructions for Test script and Test Run creation and Approval. Provided training for Test team in compliance with Company SOP and FDA guidelines.
  • Participated in ETL (Extraction Transform Load) project for Data Management.

Confidential, Louisville, CO

Software Quality Engineer

Responsibilities:

  • Participated in product development cycle by reviewing software project documentation, participating in product risk assessments, DHF review and update, Sprint planning and review, and developed appropriate verification and validation testing requirements.
  • Worked cross - functionally to implement improvements to the software life cycle, including the establishment of risk management as an overall framework for the application of appropriate software engineering methods and techniques.
  • Identify and implement software process metrics for the software product development life cycle. Develop, analyze and monitor metrics pertaining to software defects uncovered during development, testing and post-release.
  • Recommend and lead corrective and preventive actions to improve software product quality. Ensure documentation and findings are completed on time and in a timely manner in accordance with FDA and European Regulatory agency standards and procedures.
  • Participated in Non-product software validation testing of complaint handling software.
  • Reviewed and approved pocket guides and other customer facing documents.
  • Reviewed and approved test protocols for verification and validation testing.
  • Created and reviewed various risk management documents including plan/report, unresolved anomalies & risk benefit analysis.
  • Review and maintenance of Requirements traceability matrix and application of risk control measures to ensure patient and User safety.
  • Created and revised Standard Operating Procedures (SOPs) and other documentation to support the Quality System in regards to software and system design.
  • Efficient with Defect Tracking systems like TestTrack and testing systems like DOORS and TCM.
  • Worked with Sharepoint, Minitab, PLM, Microsoft Visio and other similar quality tools.
  • Follow all Quality System Practices as defined by Confidential ’s practices, policies and Standard Operating Procedures (SOPs) to ensure that FDA, ISO and European Medical Device quality standards and regulations are met where applicable.

Confidential, Ann Arbor, MI

Software Quality Engineer

Responsibilities:

  • Worked on Software Systems Design, Process Control and Quality Improvements in the manufacturing of Cardio Vascular System related medical devices.
  • Collaborated with cross-functional teams in ensuring that all software used in the production and deployments of products are compliant to software quality objectives and applicable regulations.
  • Performed, facilitated and participated in Risk Management, Software Risk Analysis, post-­-market customer feedback, Customer complain handling and CAPA management.
  • Implemented Risk based Quality Management System and Change Control methodologies.
  • Performed, assisted, reviewed and provided coordination and guidance in external validation, traceability and testability of product software.
  • Identified the testing requirements and ensured the proper test coverage of key requirements.
  • Reviewed Validation Strategy, Validation Plan, Validation Protocols (IQ/OQ/PQ), Deviation Reports, Remediation Plans and Validation Summary Reports.
  • Reviewed and updated quality system SOPs, work instructions and other documents as needed.
  • Reviewed, analyzed and reported quality system data to identify trends and identify the need for corrective and preventive actions.
  • Ensured the compliance of ISO 13485, ISO 14971, ISO 62304, CFR 820, CFR 803, CFR 11.
  • Supported Notified Body audits, customer/partner audits and FDA inspections.
  • Supported Corrective and Preventive Action (CAPA) to insure that all CAPAs involving software are correctly identified and entered into the CAPA system, assigned to the appropriate personnel, and completed according to CAPA procedures within the specified time periods.
  • Ensured that CAPA investigations are appropriate and that effective actions are being implemented.
  • Authored and Reviewed Test Strategy, Test Plan, Test Scripts, Defect Reports and Test Summary Reports.
  • Reviewed the UAT test scripts against URS to ensure the proper test coverage.
  • Ensured the compliance of 21 CFR Part 11, 820,210 and 211.
  • Performed GAP analysis to ensure adherence to all user requirements and devised Remediation Plans.
  • Assisted the development team in developing compliant templates, practices and documentation.
  • Developed and reviewed software regulatory documentation for appropriateness, correctness and effectiveness.

Quality Assurance Analyst

Confidential

Responsibilities:

  • Review and maintenance of Batch Manufacturing Records.
  • Carried out Batch testing utilizing High Proficiency Liquid Chromatography (HPLC) and other chromatography Techniques like TLC and GC to create Impurity profile of Final Product (API).
  • Participated in various quality bench tests like ph. testing, volumetric titrations, chemical tests for raw materials, intermediate products and final products for batch qualifications.
  • Performed IQ, OQ and PQ for various HPLC instruments of different make and models like Shimadzu and Waters Corporation.
  • Maintained 21 CFR part 11 compliance of HPLC software.
  • Performed instrument and Glassware calibration for various Quality Needs.
  • Carried out Stability testing of the final product from 1 month to 5 years of data.
  • Participated in review and revision of Quality SOPs. Ensured implementation of Standard quality practices for cGMP and ISO 9001:2006.
  • Participated in quality Audits for supplier and different Quality Organizations.
  • Carried out SOP and system use trainings for new and fellow colleagues

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