Engineer Quality

Akshit Reddy

*************@*****.***

Mob 224-***-****

Overall Summary:

Over 7+ years of experience as a Manufacturing Engineer with expertise in Quality Engineer, Process Validation and Test method validation in Medical device Quality domain.

Familiarity with statistical analysis methods i.e. co-relation, Principle component analysis.

Familiarity with Six Sigma and various Root Cause Analysis tools i.e. DMAIC, 5 Whys, etc.

Expertise in writing and executing Validation Protocols and authoring Reports (IQs, OQs and PQs).

Ability to assist in test method/setup optimization, test fixture optimization, test data and yield

Analysis and real-time investigation of yield and test issues for both in house and outsourced assemblies.

Proficient in MS Excel and other MS office tools

Involved in Process Validation and Test Method Validation including destructive and non-destructive methods using Nested and Crossed Gage R&R analysis.

Extensive 2D/3D CAD design experience, including expertise in Geometric Dimensioning and Tolerance (GD&T) and design for manufacturability (DFM).

Experience using continuous improvement tools, such as FMEA, Root Cause Analysis, SPC analysis, PPAP, APQP and process mapping.

Conducted Product performance Reliability and Stability studies and documented the findings.

Handled Product complaints and initiated CAPAs.

Subject matter expertise in packaging engineering or device/combination product assembly.

Experience using Statistical Process Control and process analytics

Ability to assist in test method/setup optimization, test fixture optimization, test data and yield

Proficient in developing Test Scripts, Test cases, Test plans, Test procedures and other standards.

Assisted product development in quality control procedures, development of test protocols for new equipment procurements (IQ/OQ/PQ), and introducing best practices to manufacturing.

Analysis and real-time investigation of yield and test issues for both in house and outsourced assemblies.

Knowledge of ISO, ASTM and ISTA Packaging Standards.

Experience in SolidWorks, CATIA, Pro-E ; 2D and 3D modeling experience.

Attending meetings with logical data modelers to enhance knowledge of back-end testing, like acquiring the data from different databases.

Skilled in problem solving techniques involving Lean/Six Sigma statistical tools such as: Minitab, Mat Lab, R –tool and S-tool

Experience with components of Lean Manufacturing.

Strong foundation knowledge of statistics, regression analysis, clustering, bootstrapping etc.

Experience with medical device compliance requirements based on FDA Quality Systems Regulations

Authored IQ, OQ, and PQ protocols and summary reports.

Authored Test Protocols and performed Test Method Validations.

Validated Test Fixtures, Test Assemblies and Gauges.

Ability to perform GAP analysis and preparing Remediation plans with knowledge of project Management.

Skill Set:

FMEA, Lean/Six Sigma, Validation plan, Audit Trails, Validation Summary Report, System procedures

MS Excel, MS word and MS power point, database creation in MS access

Corrective Action and Preventive Action (CAPA), Gap Analysis, Remediation Plans

ISO, ASTM and ISTA

SolidWorks, Pro-E, Minitab, R-tool, S-tool, Mat Lab, MS visual studio

21 CFR Part 11, Part 210, 211,820

Professional Summary

Baxter Healthcare., Round Lake, IL June’ 12- Present

Manufacturing Engineer

Responsibilities:

Reviewed validation (IQ/OQ/PQ/PPQ/TMV) and provided technical input to ensure validation reports were qualified to company and regulatory requirement

Performed GAP analysis for documents and process.

Experience in Validation and Verification Activities for Medical devices

Experience in handling different Test case development.

Involved in writing Test Method Validation (TMV) protocols and Final Reports.

Involved in designing test fixtures in Solidworks for performing Test Method Validation on medical devices.

Developed OQ Summary Report, PQ Summary Report and Validation Summary Report summarizing the validation activities and Deviations resulted from OQ/PQ Execution.

Repeatability and Reproducibility (R&R) studies on methods used for testing medical products.

Involved in Design Control Activities, Worked on end of life change controls, DHF Remediation.

Involved in Risk Management activities.

Responsible for authoring Risk Benefit Analysis.

Address needs for product Supplier Notice of Change testing, design/model test articles (in Pro/E), drafting studies using Good documentation practices (GDP).

Assisted in SOPs, CAPA, OOS Investigation, root cause analysis

Responsible for product design reviews, design verification and mold transfer process.

Drove supplier development by assisting them in developing problem solving control tools such as: 8D, process mapping, FMEAs, mistake proofing, SPC, Process Capability/Cpk, GD&T, Gage R&R, etc.

Assisted product development in quality control procedures, development of test protocols for new equipment procurements (IQ/OQ/PQ), and introducing best practices to manufacturing.

Managed quality assurance operations during QA Manager absence.

Assisted in procedure development and maintenance, quality validation after mold repair, including capability studies, verification and Gauge R&R, first article reports, etc.

Developed and maintained SPC database.

Developed measurement methods and designed simple fixtures to enable accurate measurement of parts.

Authored Test Protocols and performed Test Method Validations for mechanical devices.

Validated Test Fixtures, Test Assemblies and Gauges.

Zimmer, Warsaw, IN Aug’ 09- May’ 12

Validation Engineer

Responsibilities:

Facilitate Annual Risk Review and Risk Benefit Analysis, update Risk Assessment and Control Table, DHF, and Change Control documentation.

Performed Design of Experiments (DoE) using Minitab 16 and analyzed various process parameters with the use of statistical tools (SPC) such as Gage R & R, Gage linearity and Bias study, interaction plot, process capability study to optimize the blending and compression process.

Compile, analyze, and interpret preliminary experimental results using Microsoft Excel and a Minitab Statistical Software

Developed Verification/Qualification deliverables including Requirements Documents, Functional and Design Specifications, Test Protocols (IQ/OQ/PQ), and Summary Reports.

Initiate change controls into a TrackWise system.

Monitored, measured and reported manufacturing performance and developed new techniques to reduce losses and improve quality. Recommended and implemented changes to the products that improves cost, delivery, and quality for the customer.

Assured process adheres to the company quality program and planned by performing audits and recommending corrective actions. Confirmed proper documentation is on production floor for the manufacture of customer's product.

Participated in devising ways to effectively implement the principles of Lean and support a culture of continuous improvement.

Performed Quality review for validation lifecycle documentation for various medical device product families, including: Master Validation Plan, Formal Test Plan, DOE, Process Validation, Test Method Validation, Installation/Operational/Performance Qualifications, and Summary Reports.

Developed programs and methods to optimize production capability and reduce cycle time, improving manufacturing efficiency, and overall productivity.

Analyzed process to recommend floor layout and facilities justification.

Participated in overall product strategy, development, and manufacturing coordination for new and emerging products.

Reddy’s laboratories, Hyderabad June’ 08- July’ 09

Process/Quality Engineer

Responsibilities:

Assessed changes and change impact to avoid non-conformances and CAPA related issues

Authored and processed changes to manufacturing and quality systems documentation

Utilized Root Cause Analysis to drive quality systems process changes

Executed protocols to prevent overlaps, contradictions, and disconnects in documents

Activities/Deliverables of Strongest Experience and Proficiency: Equipment Life Cycle documents including but not limited to Protocols (e.g., IQ, OQ, PQ), User Requirements, Functional Requirements, Requirement/Traceability, Validation Master Plans, Test Method Validations, Design Specifications, Final Reports, FMEA and SOPs.

Identified necessary internal and external resources for completion of successful validation projects comprising of updating specification, purchasing and validating equipment and amending documents due to design change of a diagnostic device.

Extensive 2D/3D CAD design experience, including expertise in Geometric Dimensioning and Tolerance (GD&T) and design for manufacturability (DFM).

Extensive experience on Test Method Validation (TMV) for analytical, attribute and variable measurements.

Used GD&T to interpret designs, blueprints and engineering drawings.

Implemented Lean and Kaizen manufacturing principles.

FMEA and process mapping to identify supplier quality problems and formulated action plans based on analysis of the data.

Education:

Bachelor of Education in Mechanical Engineering, SRM University, Chennai India May 2009

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