Quality Assurance Validation Engineer Resume Example
QUALITY ASSURANCE VALIDATION ENGINEER
A graduate in Industrial Engineering with specialization in scheduling, logistics and supply chain management. Expertise in Job Scheduling, Production Scheduling, Six Sigma Principles, Manufacturing, Quality Control and Supply Chain Drivers. Excellent analytical skills, detail oriented, identifies opportunities and consistently achieves objectives. Focused Auditing with experience in Compliance Analysis and manufacturing validation. Insightful individual when testing systems to observe, analyze, measure and calibrate processes and equipment to drive accuracy and quality. Confident with exemplary math and auditing skills.
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- Worked as Validation Engineer on medical device research and development project to develop and execute tests for next generation of laboratory software systems.
- Create and review test protocols for verifying and validating software and system requirements
- Execute, and document process validation, capability studies and process improvement studies
- Worked with cross function teams for leading the team of Sr. testers for preparation of verification and validation protocols.
- Created and maintainedall verification and validation process documents including SOPs and desk procedures.
- Demonstrated ability to collaborate with multiple R&D and other functional leaders across sites in global environment
- · Developed process maps derived from the work procedure at supplier's end to detail the process of production.
- · Author validation/re-validation protocols, coordinated execution, performed, summarized qualification and validation activities for spinal implants and instruments
- · As a Compliance Specialist has experience for multiple clinical trials based in US, EU, Canada
- · Involved in documentation & validation of VP and plans, IQ, OQ, PQ and spreadsheet validation.
- · Validated Electronic Records and Electronic Signatures in accordance with FDA guidelines.
- · Developed standards, Processes and training for quality oversight of clinical trials
- · Worked on GxP for Adaptiv changing the Document Rev Numbers with the most updated information for easy reference.
- · Have good experience in design verification testing.; Authored protocols and reports within regulations.
- · Involved in analyzing business requirements to develop VMP, Summary Report, Test Plan, Test Cases and Test Scripts.
- · Created templates to line out the details in production arranging the Tool description with reference to the tool prints.
- · Received the Certification for FPX Training arranging the project schedule with internal teams.
- · Used FPX Formula for the assessment of project structure and alignment of operations between teams.
- · Involved in all phases of the validation lifecycle to comply with FDA regulations and GAMP.
- · Involved in entire software Validation Life Cycle, ensured the application follows 21 CFR part 11.
- · Participated in CAPA to explain process deviations and change control processes.
- · Developed, conducted and documented qualifications/ validations to ensure that the products processed are proven to be reliable, safe and effective prior to release.
- · Executed protocols and tested procedures pertaining to validation activities.
- · Conducted validation or qualification tests of new or existing products/software in accordance with internal protocols or external standards.
- · Prepared detailed inspection documentation such as written descriptions of inspection results including deviations from engineering specifications.
- · Analyzed validation test data to determine if process or systems have met criteria or to identify root cause of production problems.
- · Implemented new validation system requirements.
- · Composed reports and made adjustments to equipment or process that require improvement. Prepared equipment and document test results and maintain records for analysis.
- · Trained Manufacturing Engineers on validation concepts and regulatory requirements and expectation based on FDA guidance.
- Assembling parts for High quality competitive products for material-handling equipment.
- Worked as a machinery expertise for design and casting of Plastic Pipe production Unit.
- Lead a team of six members on a continuous improvement project using DMAIC principle and succeeded in instigating a full-time solution eradicating various manufacturing issues in the facility.
- Facilitated workouts, Value stream mapping sessions and performance.
- Assisted in production control and performance variation techniques.
- Scheduling of all the stages of production within the given constraints.
- Develop an optimized industrial process control system which helped in reduction of downtime in various instances.
- Obtain hands on experience through conducting technical meetings and authoring documentation of process parameters.
- Interpreting and Assessing data of the process at different stages using various data interpretation tools
- Managed supplier development efforts through engineering design, technical producibility, manufacturing reviews and development of solutions.
- Changed materials and finishes throughout product line to improve performance and reduce corrosion.
- Calculated overall production costs by evaluating material, labor and other expenditures.
- Observed the process and acquired knowledge about the working principle and safety requirements of Sinter plant operations and Blast furnace as the first stage of training.
- Obtained hands on working experience through participation in daily technical meetings and documentation of process parameters under the guidance of plant supervisors.
- Prepare report on the processes involved in sinter plant and blast furnace based on the acquired knowledge and functional experience.
· Indian Students Association Event Coordinator, Organizing and Managing for 200 + students, S.I.U.E, IL.
(Fall 2017-Summer 2018).
Cricket Club President S.I.U.E, Sports Club S.I.U.E, IL. (Fall 2017- Summer 2019
Energy Analysis on a Thermal System (Boiler), (Spring 2015)
Under the guidance of Dr. Tara Sheshanka, RVR & JC college of Engineering.
· The project involves energy analysis of a sub-bituminous coal based thermal boiler plant to identify the energy losses and to improve the efficiency of overall plant energy.
· Researched and investigated the energy losses in various parts of the plant such as combustor, super heater, economizer and air pre-heater.
· Supported the team members in managing the budget of the project i.e., budget involved in visiting the thermal plant.
Value Stream Mapping: Reduction of waste in mounting process of clutch discs for an auto-industry (Fall 2017)
Production Planning and Control |Southern Illinois University, Edwardsville, IL
· Drafted a value stream map for the current state and observed the lead time to improve the process efficiency and reduce production cost.
· Developed a new future state map by combining lean principles and production planning and control processes, manpower utilization increased by 10% and reduced cycle time by 7%.
· Push system is converted into pull system to create an excess inventory between the stations to result in an increased production lead time.
Kaizen for Improving the quality of the plastic liner (Spring 2018)
Lean – Kaizen Problem Solving |Southern Illinois University, Edwardsville, IL
· Executed QC 7 steps of problem solving to reduce the liner's corner scratches by 90%
· Eliminated non-value-added activity of cleaning the liner after it comes out of punching press
· Trained the operator as per the updated standard work
Projects Kaizen for reduction in frosting and door sealing issue of the freezer (Summer 2018)
· Implemented kaizen (56,5W+1H,5WHY) methodology to get to root cause of the problem
· Reduce average weekly units going into repair from 49 to only 3 units
· Performed trials on assembly line to accommodate changes and made an annual savings of $270,000
Six Sigma performance Excellence and Modern Problem Solving (Spring2019)
· Studied the defects in the assembly line for sealing the lid and the tray.
· Executed Six tools define, measure, analyze, improve and control are applied to the data in the results and outcomes are analyzed.
· Reduced the defect rate by eliminating or reducing the high frequency defects in the packing zone using six sigma tools.
Six-Sigma Quality |Southern Illinois University, Edwardsville, IL
· Studied the defects in the assembly line for sealing the lid and the tray.
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Resume Overview
School Attended
- Southern Illinois University Edwardsville
- Vignan University
Job Titles Held:
- Quality Assurance Validation Engineer
- Process Validation Engineer, Compliance Specialist
- Manufacturing Engineer, Auditor
- Engineering Intern
Degrees
- Master of Science : Industrial Engineering
Bachelor of Engineering : Mechanical Engineering
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